<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299452</url>
  </required_header>
  <id_info>
    <org_study_id>Alphacait 001</org_study_id>
    <nct_id>NCT03299452</nct_id>
  </id_info>
  <brief_title>Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor</brief_title>
  <official_title>Clinical Studies by Using Alphacait to Screen Drug Combinations for Advanced Solid Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haining Health-Coming Biotech Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alphacait, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Haining Health-Coming Biotech Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-center, open-label, single-arm, non-randomized study designed to evaluate&#xD;
      PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR)&#xD;
      and biomarkers of cancer therapy based on Alphacait screening system in subjects with&#xD;
      advanced malignant tumor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tumor heterogeneity leads to a significant difference in the rate of response to drugs in&#xD;
      patients with the same pathological type. According to the information, the current initial&#xD;
      effective rate of domestic and foreign chemotherapeutic single drug is no more than 30%, even&#xD;
      if treated with repeated medication or replacement treatment program, the responsive rate is&#xD;
      generally not more than 10%. This heterogeneity of tumor is the biological basis of precision&#xD;
      medicine, and how to predict cancer drug sensitivity is a clinical need to solve the&#xD;
      practical problems.&#xD;
&#xD;
      Traditional PDX (patient-derived engraft) technology utilizes patient's fresh tumor tissue&#xD;
      (containing tumor cells, stromal cells and vascular components), and inoculates in&#xD;
      immunodeficient mice to establish mouse tumor model. This method can better reflect the true&#xD;
      biological characteristics of tumor, while the mouse tumor tissue can be continuously passed&#xD;
      on, and greatly facilitate tumor biology research. According to the transplant site it can be&#xD;
      divided into orthotopic transplantation and ectopic transplantation (mostly subcutaneous or&#xD;
      renal transplantation). However, the traditional PDX model has its disadvantage of low&#xD;
      success rate and time consuming. Most of the tumor matrix after transplantation can be&#xD;
      replaced by the corresponding components in mice, leading to differences in the biological&#xD;
      properties of the original tumor.&#xD;
&#xD;
      In view of this imperfection, we developed an optimized drug selection model based on the&#xD;
      Alphacait screening system that combines artificial intelligence, synthetic lethal and&#xD;
      combinational chemistry, which allows rapid selection of candidates from millions of drug&#xD;
      combinations. We want to provide physicians with individualized drug therapy through a new in&#xD;
      vitro and in vivo drug-sensitive screening technique, to achieve rapid and accurate selection&#xD;
      of cancer clinical treatment.&#xD;
&#xD;
      In order to achieve the two key requirements of tumor tissue culture system in vitro, the&#xD;
      establishment of tumor microenvironment we introduced the millimeter-sized microbeads, based&#xD;
      on combinatorial chemistry in the culture medium. The surface of the microbeads is coated&#xD;
      with small molecules that can specifically absorb high levels of metabolites secreted by the&#xD;
      tumor cells into the matrix, thereby mimicking in vivo circumstances. In short, we&#xD;
      innovatively applied microbeads technology to solve the inherent limitations of 3D organoid&#xD;
      culture - no blood circulation in vitro.&#xD;
&#xD;
      Purpose and design Primary endpoint: progression-free survival (PFS) Secondary endpoints:&#xD;
      overall survival (OS); disease control rate (DCR), objective response rate (ORR); safety;&#xD;
      blood test and gene test in the aspect of biomarkers. Expectations of exploratory markers for&#xD;
      this study include the status of exploratory biomarkers associated with immunohistochemistry&#xD;
      (IHC) or quantitative reverse transcription polymerase chain reaction (qRT-PCR), a new&#xD;
      generation sequencing method (NGS), Nanostring technique and / or other methods to evaluate&#xD;
      archived and/or newly acquired tumor tissue, as well as its association with disease status&#xD;
      and/or (Including but not limited to somatic mutations and other exploratory markers)&#xD;
      according to qRT-PCR and NGS techniques, and to evaluate the relationship between the&#xD;
      therapeutic response, the status of the biomarker during exploratory treatment and during&#xD;
      treatment, and the evaluation of plasma, serum or whole blood samples (including but not&#xD;
      limited to somatic mutations and other exploratory markers) The association of the above&#xD;
      markers with disease status and / or therapeutic response.&#xD;
&#xD;
      Research design This is a single-center, open-label, single-arm, non-randomized study&#xD;
      designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR),&#xD;
      disease control rate (DCR) and biomarkers of cancer therapy based on the Alphacait screening&#xD;
      system in subjects with advanced malignant tumor.&#xD;
&#xD;
      List of drugs used by the Alphacait screening system is as follow:&#xD;
&#xD;
      Non chemotherapy drug&#xD;
&#xD;
      Albendazole Tablets, Alfacalcidol Soft Capsules, Aripiprazole Tablets, Anastrozole Tablets,&#xD;
      Azithromycin, Acyclovir Dispersible Tablets, Aztreonam, OLanzapine Tablets, Omeprazole&#xD;
      Enteric-coated Capsules, Ornidazole and Sodium Chloride Injection, resveratrol, citicoline&#xD;
      sodium injection, Bevacizumab，Avastin, Phenobarbital, Amlodipine Besylate Tablets, phenytoin&#xD;
      sodium tablet, Piroxicam tablets, Allopurinol tablets, Propylthiouracil Tablets, Sodium&#xD;
      Valproate for Injection, Nuprin Tablets, Goserelin Acetate Sustained-Release Depot, Zoladex,&#xD;
      Megestrol Acetate Dispersible Tablets, Prednisone Acetate Tablets, Desmopressin Acetate&#xD;
      Injection, Low-molecular-weight Heparin Sodium Injection, Digoxin Tablets, Dexamethasone&#xD;
      Sodium phosphate Injection, Bacillus Licheniformis Capsule, tabellae paracetamol, Levodopa&#xD;
      and Benserazide Hydrochloride Tablets, Domperidone Tablets, Metformin, Famotidine tablets,&#xD;
      Fenbendazole, Nitrofurantoin Enteric-coated Tablets, Fluconazole and Sodium Chloride&#xD;
      Injection, Haloperidol Injection, Flupentixol and Melitracen Tablets, Compound Zedoary&#xD;
      Turmeric Oil Suppositories, Compound Sulfamethoxazole Injection, Compound Hypotensive&#xD;
      Tablets, Bisoprolol Fumarate Tablets, Quetiapine Fumarate Tablets, Injection Mannitou,&#xD;
      Heparin sodium, Bismuth Potassium Citrate Tablets, Banan tablet, Erythromycin enteric&#xD;
      capsules, Metoprolol succinate sustained-release tablets, Warevan tablet, Huaier granule,&#xD;
      Cyclosporine, Progesterone injection, Gabapentin capsules, Mebendazole Chewable Tablets,&#xD;
      Apatinib Mesylate, Phentolamine Mesylate Injection, Imatinib Mesylate, Neostigmine&#xD;
      Methylsulfate Injection, Imatinib Mesylate Tablets, Thiamazole Tablets, Metronidazole,&#xD;
      Colloidal Bismuth Pectin Capsules, Metoprolol Tartrate Tablets, Carbamazepine Tablets,&#xD;
      Captopril Tablets, Clarithromycin Sustained-release Tablets, Clindamycin Phosphate Injection,&#xD;
      Lamictal, Letrozole Tablets, Lara chips, Tripterygium Glycosides, Atorvastatin, Ribavirin&#xD;
      injection, Rifampicin Capsules, Risperidone Tablets, Primaquine Diphosphate, Chloroquine&#xD;
      Phosphate Tablets, Amikacin Sulfate Injection, Atropine sulphate injection, Magnesium sulfate&#xD;
      injection, Azathioprine Tablets, Sulfasalazine Enteric-coated Tablets, Roxithromycin Soft&#xD;
      Capsules, Clozapine Tablets, Desloratadine Tablets, Flupirtine Maleate, Fluvoxamine Maleate&#xD;
      Tablets, Chlorphenamine Maleate Tablets, Enalapril Maleate Tablets, Meloxicam, Mesalazine&#xD;
      Enteric-coated Tablets, Mirtazapine, Naproxen Tablets, Nikethamide Injection, Nimodipine&#xD;
      Injection, Nitrendipine Tablets, Norfloxacin Capsules, Hydroxycarbamide Tablets, Artemisinin,&#xD;
      Benzylpenicillin sodium, Hydrocortisone Injection, Citalopram Hydrobromide Tablets,&#xD;
      Gentamicin, Colchicine Tablets, Doxifluridine Capsules, Deslanoside Injection, Ciprofloxacin&#xD;
      Lactate and Sodium Chloride Injection, Celecoxib Capsules, Trifluoperazine, Tetrastigma&#xD;
      hemsleyanum Diels et Gilg, Thalidomide Tablets, Sulpiride Tablets, Diclofenac Potassium&#xD;
      Capsules, Clostridium butyricum TO-A, Dihydroartemisinin and Piperaquine Phosphate Tablets,&#xD;
      Tetracycline Tablets, Lithium Carbonate Sustained-release Tablets, Tegafur Injection,&#xD;
      Teicoplanin, Tinidazole and Sodium Chloride Injection, Cefoxitin, Ceftizoxime Sodium,&#xD;
      Topiramate Tablets, Vancomycin, Tretinoin Tablets, Vemurafenib, Vitamin A, Vitamin B2&#xD;
      Tablets, Vitamin D2 Injection, Cimetidine Tablets, Cimetidine Injection, Nifedipine Sustained&#xD;
      Release Tablets, Nitroglycerin Injection, Isosorbide Dinitrate Injection, Valsartan&#xD;
      Dispersible Tablets, Simvastatin Tablets, Thymalfasin, Ursodeoxycholic Acid, Folic acid&#xD;
      calcium salt hydrate, Amitriptyline Hydrochloride Tablets, Bupropion Hydrochloride&#xD;
      Sustained-Release Tablets, Amiodarone Hydrochloride Tablets, Ondansetron Hydrochloride&#xD;
      Injection, Betahistine Hydrochloride Injection, Diphenhydramine Hydrochloride Injection,&#xD;
      Bupropion Hydrochloride Injection Tablets, 3-Hydroxytyramine hydrochloride, Doxepin&#xD;
      Hydrochloride, Flunayizine Hydrochloride Capsules, Prozac, Metoclopramide Dihydrochloride&#xD;
      Injection, Arginine Hydrochloride Injection, Clindamycin Hydrochloride Injection, Raloxifene&#xD;
      Hydrochloride Tablets, Ranitidine Hydrochloride Capsules, Lidocaine Hydrochloride Injection,&#xD;
      Lobeline Hydrochloride Injection,, Chlorpromazine, Clomipramine Hydrochloride Tablets,&#xD;
      Omeprazole Magnesium Enteric-coated Tablets, Mexiletine Hydrochloride Tablets, Paroxetine&#xD;
      Hydrochloride Tablets, Procaine Hydrochloride for Injection, Trazodone Hydrochloride Tablets,&#xD;
      Daunorubicin hydrochloride, Cyproheptadine Hydrochloride Tablets, Sertraline Hydrochloride&#xD;
      Tablets, Tamsulosin Hydrochloride Sustained Release Capsules, Terazosin Hydrochloride&#xD;
      Tablets, Verapamil Hydrochloride Tablets, Venlafaxine Hydrochloride Capsules, Raceanisodamine&#xD;
      Hydrochloride Injection, Berberine Hydrochloride Tablets, Ethambutol Hydrochloride Tablets,&#xD;
      Levofloxacin Hydrochloride for Injection, Itraconazole, Ivermectin,&#xD;
      IPTG；Isopropyl-β-D-thiogalactoside, Isopropyl-beta-D-thiogalactopyranoside, Isoniazid&#xD;
      Tablets, Indapamide Tablets, Indomethacin Enteric-coated Tablets, Amoxicillin Sodium and&#xD;
      Clavulanate Potassium for injection, Azithromycin for Injection, Acyclovir for Injection,&#xD;
      Ampicillin Sodium Injection, Omeprazole Sodium for Injection, Oxacillin Sodium for Injection,&#xD;
      Biapenem for Injection, Benzathine Penicillin For Injection, Sodium Valproate for Injection,&#xD;
      Ganciclovir, Fosfomycin Sodium for Injection, Asparaginase, Urokinase for Injection,&#xD;
      Piperacillin Sodium for Injection, Artesunate for Injection, Sodium Nitroprusside, Diltiazem&#xD;
      Hydrochloride for Injection, Recombinant Human Interferon gamma for Injection,&#xD;
      Levobupivacaine, Levothyroxine Sodium Tablets, Levofloxacin Tablets&#xD;
&#xD;
      Chemotherapy and target therapy drugs&#xD;
&#xD;
      Aidi injection, Oxaliplatin for Injection, Epirubicin, Dacarbazine, Dabrafenib, mesylate,&#xD;
      Dabratinib, Dasatinib Tablets, Sorafenib Tosylate Tablets, Doxorubicin, Docetaxel,&#xD;
      5-Fluorouracil, Juyuansuan Tamoxifen, Cino bufotalin, Cyclophosphamide, Gefitinib (pure)&#xD;
      powder, Gemcitabine hydrochloride, Methotrexate, Carboplatin, Capecitabine, Kanglaite&#xD;
      Injection, Raltitrexed, Mabthera, Lobaplatin for Injection, Mitoxantrone, Nedaplatin,&#xD;
      Mercaptopurine, Cisplatin, Mitomycin for Injection, Tacrolimus, Tegafur, Gimeracil and&#xD;
      Oteracil Potassium, Temozolomide, Cetuximab Solution for Infusion, Lobaplatin for Injection,&#xD;
      Mitoxantrone, Nedaplatin, Mercaptopurine, Cisplatin, Mitomycin for Injection, Tacrolimus,&#xD;
      Tegafur, Gimeracil and Oteracil Potassium, Temozolomide, Cetuximab Solution for Infusion&#xD;
&#xD;
      Chinese Herb Medicine&#xD;
&#xD;
      English Name Latin Name Job's tears seed Coicis Semen, Japanese Ardisia Herb Japanese Ardisia&#xD;
      Herb, White Hyacinth Bean Semen Dolichoris Album, Spreading Hedyotis Herb Hedyotis diffusa,&#xD;
      Willowleaf Swallowwort Rhizome Rhizoma Cynanchi Stauntonii, Large head Atractylodes Rh&#xD;
      Rhizoma Atractylodis Macrocephalae, Sessile Stemona Root Japanese Stemona Root, Lily Lilium&#xD;
      brownii var. viridulum, Seman Platycladi Seman, Isatis root Isatis tinctoria, Herba Lobeliae&#xD;
      Chinensis Lobelia chinensis Lour, Pinellia ternata Pinellia ternata (Thunb.) Breit,&#xD;
      Scutellaria barbata Scutellaria barbata, CoasiaI GIehnia Root Glehnia littoralis, Fritillary&#xD;
      fritillary, Ficus pumila Linn Ficus pumila, Seed-coat of Hyacinth Dolichos, Areca Seed, Betel&#xD;
      Nut Semen Arecae, Malaytea Scurfpea Fruit Fructus Psoraleae, Semen raphani , Silkworm shit&#xD;
      Faeces Bombycis, Siberian Cocklour Fruit Fructus Xanthii, Rhizome of Swordlike Atractylodes&#xD;
      Rhizoma Atractylodis, Root of Chinese Thorowax Radix Bupleuri, Radices paeoniae rubra&#xD;
      Paeoniae Rubra Radix, Dan - shen Root Salviae Miltiorrhizae Radix, Tree Peony Root - bark&#xD;
      Moutan Radicis Cortex, Chinese Goldthread Rhizome Coptidis Rhizoma, Skunk Bugbane Rhizome&#xD;
      Cimicifugae Foetidae Rhizoma, Coix seed Semen Coicis Szechwan Chinaberry Fruit Fructus Meliae&#xD;
      Toosendan, Radix Cyathulate Radix Cyathulae, Common Andrographis Herb Herba Andrographis,&#xD;
      Radix et Caulis Acanthopanacis Senticosi Radix et Caulis Acanthopanacis Senticosi, Japanese&#xD;
      Thistle Herbor Root Herba seu Radix Cirsii Japonici, Indigowoad Leaf, Leaf of Indigowoad&#xD;
      Folium Isatidis, Danshen Root, Root of Dan-shen Salviae Miltiorrhizae Radix et Rhizoma, Root&#xD;
      of Pilose Asiabell Radix Codonopsis, Fructus Oryzae Germinatus Fructus Oryzae Germinatus,&#xD;
      Humifuse Euphorbia Herb Herba Euphorbiae Humifusae, Chinese Waxgourd Peel Exocarpium&#xD;
      Benincasae, Waxgourd seed Semen Benincasae, Rabdosia rubesens,hamst Rabdosia rubescens,&#xD;
      Rhioxma Curcumae Aeruginosae Rhizoma Curcumae, Divaricate Saposhnikovia RootRadix&#xD;
      Saposhnikoviae, Indian Buead Poria, Pine among the Indian Bread, Blighted Wheat Fructus&#xD;
      Tritici Levis, Radix Glycyrrhizae Radix Glycyrrhizae, Toad skin, Perfoliate Knotweed Herb&#xD;
      Polygonum perfoliatum, Ligusticum sinense Oliv Rhizoma Ligustici, Barbary Wolfberry Fruit&#xD;
      Fructus Lycii, Herba Pogostemonis Herba Pogostemonis, Sargassum Sargassum, Yerbadetajo Herb&#xD;
      Herba Ecliptae Eclipta prostrala, Terminalia chebula Retz, Taxus chinensis Taxus chinensis&#xD;
      (Pilger) Rehd, Flos Carthami Flos Carthami, Root of Kirilow Rhodiola Herba Rhodiolae,&#xD;
      Figwortflower Picrorhiza Rhizome Rhizoma Picrorhizae, Polygonum cuspidatum Rhizoma Polygoni&#xD;
      Cuspidati, Pricklyash Peel Pericarpium Zanthoxyli, Talcum Talcum, Exocarpium Citri Grandis&#xD;
      Exocarpium Citri Grandis, Phellodendron Chinese Schneid Cortex Phellodendri, Manyflower&#xD;
      Solomonseal Rhizome Rhizoma Polygonati, Radix Astragali Radix Astragali seu Hedysari, Radix&#xD;
      Scutellariae, Flos Celosiae Cristae Flos Celosiae Cristatae, Suberect Spatholobus Stem Caulis&#xD;
      Spatholobi, Rhizoma Curcumae Longae Rhizoma Curcumae Longae, Christina Loosestrife HerbHerba&#xD;
      Lysimachiae, Japanese Honysuckle Flower Bud Flos Lonicerae, Cherokee Rose Fruit Fructus Rosae&#xD;
      Laevigatae, Chrysanthemum flower Flos Chrysanthemi, Spikemoss Herba Selaginellae, Cassia seed&#xD;
      Semen Cassiae, Lightyellow sophora root Radix Sophorae Flavescentis, Kelp Laminariae Thallus,&#xD;
      Semen Litchi Semen Litchi, Chinese trumpet creeper Campsis grandiflora, Diverse Wormwood Herb&#xD;
      Herba Artemisiae Anomalae, Radix Gentianae Gentiana Scabra Bunge, Reed Rhizome Stemmacanthae&#xD;
      Unifori Radix, Caulis Trachelospermi Trachelospermi Jasminoidis Caulis, Lv Bean Spermodermis&#xD;
      Phaseoli Radiati, European Verbena Herb Herba Verbenae Officinalis, Herba Portulacae&#xD;
      Portulaca oleracea L, Radix Ophiopogonis Ophiopogonis Radix, Fructus Hordei Germinatus Hordei&#xD;
      Germinatus Fructus, Concha Ostreae Concha Ostreae, Costustoot, Common Vladimiria Root&#xD;
      Aucklandiae Radix, Fructus Ligustri Lucidi Ligustri Lucidi Fructus, Fortune Eupatorium Herb&#xD;
      Eupatorii Fortunei Herba, Folium Eriobotryae Eriobotryae Japonicae Folium, Dandelion Herba&#xD;
      Taraxaci, Flower of Shepherdspurse Capsella bursa-pastoris (L.)Medic), Rhizoma Homalomenae&#xD;
      Rhizoma Homalomenae, Gordon Enryale Seed Euryales Semen, Radix Gentinae Gentianae&#xD;
      Macrophyllae Radix, Cortex Fraxini Fraxini Cortex, Caulis SinomeniiI Caulis Sinomenii, Semen&#xD;
      Celosiae Celosiae Argenteae Semen, Herba Dianthi Dianthi Superbi Herba, Caulis Lonicerae&#xD;
      Lonicerae Caulis, Cortex CinnamoniCinnamomi Cassiae Cortex, Rhizoma Srarganii Rhizoma&#xD;
      Sparganii, Sanchi Panax pseudo-ginseng var, Radix tetrastigme Tetrastigma hemsleyanum Diels&#xD;
      et Gilg, Folium Mori Mori Folium, Chinese yam Dioscorea opposite, Amorphophallus rivieri&#xD;
      Durieu Amorphophallus rivieri Durieu, Snake venom, Snake Slough Serpentis Periostracum,&#xD;
      Rhizoma Belamcandae rhizoma belamcandae, Largetrifoliolious Bugbane RhizmomeRhizoma&#xD;
      Cimicifugae, Radix Sanguisorbae SanguisorbaofficinalisL, Eucommia ulmoides Oliver Eucommia&#xD;
      ulmoides, Rhizoma Zingiberis RecensZingiber officinale Roscoe, Salvia chinensis Benth Salvia&#xD;
      chinensis Benth, Folium Photiniae Photinia serrulata Lindl, Lignum Sappan Lignum Sappan,&#xD;
      Semen Persicae Semen Persicae, Radix Asparagi Radix Asparagi, Root of Nakedcaule Groundsel&#xD;
      Radix Semiaquilegiae, Root of Common carpesium Herba Carpesii Abrotanoidis, Semen lepidii&#xD;
      Semen Lepidii, Herb of Tuberculate Speranskia Phryma leptostachya L. subsp. asiatica (Hara),&#xD;
      China Dodder Semen Cuscutae, Semen Vaccariae Semen Vaccariae, Herb of Coffee Senna Cassia&#xD;
      occidentalis Linn, Fructus Mume Fructus Mume, Root of Combined Spicebush Radix Linderae, Fig&#xD;
      Ficus carica Linn, Medicinal Evodia Fruit Evodia rutaecarpa (Juss.) Benth, Chinese Gall,&#xD;
      Chinese Nut-gall Rhus chinensis Mill, Sessileflower Acanthopanax Bark Cortex Acanthopanax&#xD;
      Radicis, All-grass of Bluecalyx Japanese Rabdosia, Fructus Foeniculi Fructus Foeniculi,&#xD;
      Common Cephalanoplos Herb Cirsium setosum (Willd.) MB, Flos Magnoliae Flos Magnoliae,&#xD;
      Paniculate Swallowwort Root Cynanchum paniculatum (Bunge) Kitagawa, Linseed,seed of Flax&#xD;
      Linseed seed of Flax, Fructus Alpiniae Oxyphyllae Alpinia oxyphylla Miq, Job's tears seed&#xD;
      Semen Coicis, Herba Artemisiae Scopariae ArtemisiacapillarisThunb, Folium Ginkgo&#xD;
      Ginkgobiloba, Heartleaf Houttuymia Herb Houttuynia cordata Thunb, Turmeric Root-tuber Radix&#xD;
      Curcumae, Akebia Fruit Foreknowledge, Hiraute Shiny Bugleweek Herb Aconitum gymnandrum Maxim,&#xD;
      Rhizoma Paridis RhizomaParidis, Polyporus Polyporus, Root of Sinkiang Arnebia Lithospermum&#xD;
      erythrorhizon Sieb. et Zucc, Herba Violae Viola yedoensis Makino, Fluoritum Fluoritum Caulis&#xD;
      Perillae Perilla frutescens （L.）Britton&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This single center, open-label, single arm, non-randomized study is designed to evaluate safety, progression-free survival(PFS),overall survival (OS), objective response rate (OPR), and disease control rate (DCR) of chemotherapy or target therapy or chinese medicine based on the Alphacait screening system in subjects with advanced malignant tumor.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival(PFS)</measure>
    <time_frame>36 months</time_frame>
    <description>Progression-free survival (PFS) is defined as the time from assignment in the trial to disease progression or death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival(OS)</measure>
    <time_frame>36 months</time_frame>
    <description>Defined as the time from assignment to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>36 months</time_frame>
    <description>Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate(DCR)</measure>
    <time_frame>36 months</time_frame>
    <description>Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response or stable disease to therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>36 months</time_frame>
    <description>Drug-related adverse reactions must be recorded, mainly in the following：myelosuppression including neutropenia, anemia and thrombocytopenia;Cardiac toxicity; muscle fatigue, pain, imbalance; Oral ulcers: the patient's gums, cheeks, throat and tongue are prone to ulcers;nausea, vomiting, constipation or diarrhea;hair loss;skin discomfort;hormonal fluctuations, sexual dysfunction, infertility; damage of the kidney;anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers</measure>
    <time_frame>36months</time_frame>
    <description>Expectations of exploratory markers for this study include the status of exploratory biomarkers associated with immunohistochemistry (IHC) or quantitative reverse transcription polymerase chain reaction (qRT-PCR), a new generation sequencing method (NGS), Nanostring technique and / or other methods to evaluate archived and/or newly acquired tumor tissue, as well as its association with disease status and/or (Including but not limited to somatic mutations and other exploratory markers) according to qRT-PCR and NGS techniques, and to evaluate the relationship between the therapeutic response, the status of the biomarker during exploratory treatment and during treatment, and the evaluation of plasma, serum or whole blood samples (including but not limited to somatic mutations and other exploratory markers) The association of the above markers with disease status and / or therapeutic response.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Metastatic Cancer</condition>
  <arm_group>
    <arm_group_label>Alphacait-guided therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines until the patient progresses, intolerant, the patient withdrawn or the investigator determines that the medication must be discontinued.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Non Chemotherapy</intervention_name>
    <description>Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.</description>
    <arm_group_label>Alphacait-guided therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy and target therapy</intervention_name>
    <description>Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.</description>
    <arm_group_label>Alphacait-guided therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chinese herb medicine</intervention_name>
    <description>Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.</description>
    <arm_group_label>Alphacait-guided therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Advanced recurrent or metastatic malignant tumor confirmed by pathological diagnosis;&#xD;
&#xD;
          2. At least one measurable malignant lesion;&#xD;
&#xD;
          3. Failed previous standard treatment or with tumor recurrence, and no standard&#xD;
             therapeutic regimen available;&#xD;
&#xD;
          4. No radiation therapy within last four weeks or recovered from last radiation related&#xD;
             acute complication, if applicable; prophylactic brain radiation therapy or palliative&#xD;
             radiation treatment for bone metastasis is acceptable;&#xD;
&#xD;
          5. No gender requirement and must be no younger than18 years old;&#xD;
&#xD;
          6. ECOG PS: score 0-2;&#xD;
&#xD;
          7. Life expectancy more than three months;&#xD;
&#xD;
          8. Patient's organ function level should meet these criteria:&#xD;
&#xD;
        (1) CBC should meet these criteria: ANC≥1.5×109 /L，PLT≥100×109/L，Hb≥ 100 g/L; (2) Chemistry&#xD;
        should meet these criteria: TBIL&lt;1.5×ULN，ALT、AST&lt; 2.5×ULN（if with liver metastasis&#xD;
        ALT、AST&lt;5×ULN） BUN and Cr ≤1×ULN or Cr clearance ≥50ml/min（Cockcroft-Gault formula） 9.&#xD;
        Agree to use appropriate contraceptive measure during the study period and until 8 weeks&#xD;
        after the last study drug is given. Or patient has been surgically sterilized.&#xD;
&#xD;
        10. Qualified candidate should voluntarily participate this study, sign informed consent&#xD;
        forms and be compliant with the study protocols and follow-up visit(s).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Symptomatic brain metastasis (could still enroll into the study if treatment finished&#xD;
             21 days prior to the enrollment and the patient is stable, but brain MRI, CT or&#xD;
             angiogram is needed to rule out no intracranial hemorrhage)&#xD;
&#xD;
          2. Following cardiac disease: second-degree or above cardiac ischemia or myocardial&#xD;
             infarction, uncontrolled arrhythmias (including QTc interval male&gt;450 ms,&#xD;
             female&gt;470ms), according to NYHA criteria, III to IV cardiac insufficiency, or&#xD;
             echocardiogram reveals left ventricular ejection fraction (LVEF) &lt;50%;&#xD;
&#xD;
          3. History of pulmonary interstitial lung disease or active interstitial lung disease;&#xD;
&#xD;
          4. Coagulation dysfunction (INR &gt;1.5 or PT&gt;ULN+ 4sec, or PTT&gt;1.5 ULN), with bleeding&#xD;
             tendency or currently receiving thrombolysis therapy or anticoagulation treatment;&#xD;
&#xD;
          5. Clinical bleeding episode or bleeding tendency within past three months, such as GI&#xD;
             bleeding, hemorrhagic gastric ulcer, stool guaiac++ positive, or with vasculitis；&#xD;
&#xD;
          6. Arterial or venous thrombosis within last 12 months, such as various types of CVA, DVT&#xD;
             or PE patients;&#xD;
&#xD;
          7. Known hereditary or acquired bleeding or hypercoagulable state (such as hemophilia,&#xD;
             coagulating dysfunction, thrombocytopenia, hypersplenism);&#xD;
&#xD;
          8. Major surgery, trauma, fracture or ulcer within past 4 weeks;&#xD;
&#xD;
          9. Active infection requiring antibiotics, antifungal or antiviral treatment;&#xD;
&#xD;
         10. Patient has a history of psychiatric medication abuse and cannot be abstinent from the&#xD;
             psychiatric medication, or with mental disorder;&#xD;
&#xD;
         11. Participation of other cancer chemotherapy clinical study within past 4 weeks;&#xD;
&#xD;
         12. History of uncured coexisting cancer, no including cured basal cell carcinoma,&#xD;
             cervical cancer in situ, or superficial bladder cancer;&#xD;
&#xD;
         13. Pregnant or breast feeding women; fertile patients no willing or able to take&#xD;
             effective contraceptive measures;&#xD;
&#xD;
         14. Any circumstances that might affect the proceeding of the clinical trial and/or&#xD;
             research result analysis, as determined by the clinical investigator(s).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haizhou Lou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linghua Zhu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Enguo Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bin Li, MD</last_name>
    <phone>86-137-50766911</phone>
    <email>yanfangren1019@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Haizhou Lou, MD</last_name>
    <phone>86-571-86006926</phone>
    <email>louhz09@aliyun.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haizhou Lou, MD</last_name>
      <phone>86-571-86006926</phone>
      <email>louhz09@aliyun.com</email>
    </contact>
    <contact_backup>
      <last_name>Ming Xu</last_name>
      <phone>86-571-86006811</phone>
      <email>xuminghnu@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Haizhou Lou, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ex vivo high-throughput drug screening assay</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Through publication after study completion</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>12/31/2018</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299452
org study id: Alphacait 001
nct id: NCT03299452
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a single-center, open-label, single-arm, non-randomized study designed to evaluate
      PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR)
      and biomarkers of cancer therapy based on Alphacait screening system in subjects with
      advanced malignant tumor.
Tumor heterogeneity leads to a significant difference in the rate of response to drugs in
      patients with the same pathological type. According to the information, the current initial
      effective rate of domestic and foreign chemotherapeutic single drug is no more than 30%, even
      if treated with repeated medication or replacement treatment program, the responsive rate is
      generally not more than 10%. This heterogeneity of tumor is the biological basis of precision
      medicine, and how to predict cancer drug sensitivity is a clinical need to solve the
      practical problems.

      Traditional PDX (patient-derived engraft) technology utilizes patient's fresh tumor tissue
      (containing tumor cells, stromal cells and vascular components), and inoculates in
      immunodeficient mice to establish mouse tumor model. This method can better reflect the true
      biological characteristics of tumor, while the mouse tumor tissue can be continuously passed
      on, and greatly facilitate tumor biology research. According to the transplant site it can be
      divided into orthotopic transplantation and ectopic transplantation (mostly subcutaneous or
      renal transplantation). However, the traditional PDX model has its disadvantage of low
      success rate and time consuming. Most of the tumor matrix after transplantation can be
      replaced by the corresponding components in mice, leading to differences in the biological
      properties of the original tumor.

      In view of this imperfection, we developed an optimized drug selection model based on the
      Alphacait screening system that combines artificial intelligence, synthetic lethal and
      combinational chemistry, which allows rapid selection of candidates from millions of drug
      combinations. We want to provide physicians with individualized drug therapy through a new in
      vitro and in vivo drug-sensitive screening technique, to achieve rapid and accurate selection
      of cancer clinical treatment.

      In order to achieve the two key requirements of tumor tissue culture system in vitro, the
      establishment of tumor microenvironment we introduced the millimeter-sized microbeads, based
      on combinatorial chemistry in the culture medium. The surface of the microbeads is coated
      with small molecules that can specifically absorb high levels of metabolites secreted by the
      tumor cells into the matrix, thereby mimicking in vivo circumstances. In short, we
      innovatively applied microbeads technology to solve the inherent limitations of 3D organoid
      culture - no blood circulation in vitro.

      Purpose and design Primary endpoint: progression-free survival (PFS) Secondary endpoints:
      overall survival (OS); disease control rate (DCR), objective response rate (ORR); safety;
      blood test and gene test in the aspect of biomarkers. Expectations of exploratory markers for
      this study include the status of exploratory biomarkers associated with immunohistochemistry
      (IHC) or quantitative reverse transcription polymerase chain reaction (qRT-PCR), a new
      generation sequencing method (NGS), Nanostring technique and / or other methods to evaluate
      archived and/or newly acquired tumor tissue, as well as its association with disease status
      and/or (Including but not limited to somatic mutations and other exploratory markers)
      according to qRT-PCR and NGS techniques, and to evaluate the relationship between the
      therapeutic response, the status of the biomarker during exploratory treatment and during
      treatment, and the evaluation of plasma, serum or whole blood samples (including but not
      limited to somatic mutations and other exploratory markers) The association of the above
      markers with disease status and / or therapeutic response.

      Research design This is a single-center, open-label, single-arm, non-randomized study
      designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR),
      disease control rate (DCR) and biomarkers of cancer therapy based on the Alphacait screening
      system in subjects with advanced malignant tumor.

      List of drugs used by the Alphacait screening system is as follow:

      Non chemotherapy drug

      Albendazole Tablets, Alfacalcidol Soft Capsules, Aripiprazole Tablets, Anastrozole Tablets,
      Azithromycin, Acyclovir Dispersible Tablets, Aztreonam, OLanzapine Tablets, Omeprazole
      Enteric-coated Capsules, Ornidazole and Sodium Chloride Injection, resveratrol, citicoline
      sodium injection, Bevacizumab，Avastin, Phenobarbital, Amlodipine Besylate Tablets, phenytoin
      sodium tablet, Piroxicam tablets, Allopurinol tablets, Propylthiouracil Tablets, Sodium
      Valproate for Injection, Nuprin Tablets, Goserelin Acetate Sustained-Release Depot, Zoladex,
      Megestrol Acetate Dispersible Tablets, Prednisone Acetate Tablets, Desmopressin Acetate
      Injection, Low-molecular-weight Heparin Sodium Injection, Digoxin Tablets, Dexamethasone
      Sodium phosphate Injection, Bacillus Licheniformis Capsule, tabellae paracetamol, Levodopa
      and Benserazide Hydrochloride Tablets, Domperidone Tablets, Metformin, Famotidine tablets,
      Fenbendazole, Nitrofurantoin Enteric-coated Tablets, Fluconazole and Sodium Chloride
      Injection, Haloperidol Injection, Flupentixol and Melitracen Tablets, Compound Zedoary
      Turmeric Oil Suppositories, Compound Sulfamethoxazole Injection, Compound Hypotensive
      Tablets, Bisoprolol Fumarate Tablets, Quetiapine Fumarate Tablets, Injection Mannitou,
      Heparin sodium, Bismuth Potassium Citrate Tablets, Banan tablet, Erythromycin enteric
      capsules, Metoprolol succinate sustained-release tablets, Warevan tablet, Huaier granule,
      Cyclosporine, Progesterone injection, Gabapentin capsules, Mebendazole Chewable Tablets,
      Apatinib Mesylate, Phentolamine Mesylate Injection, Imatinib Mesylate, Neostigmine
      Methylsulfate Injection, Imatinib Mesylate Tablets, Thiamazole Tablets, Metronidazole,
      Colloidal Bismuth Pectin Capsules, Metoprolol Tartrate Tablets, Carbamazepine Tablets,
      Captopril Tablets, Clarithromycin Sustained-release Tablets, Clindamycin Phosphate Injection,
      Lamictal, Letrozole Tablets, Lara chips, Tripterygium Glycosides, Atorvastatin, Ribavirin
      injection, Rifampicin Capsules, Risperidone Tablets, Primaquine Diphosphate, Chloroquine
      Phosphate Tablets, Amikacin Sulfate Injection, Atropine sulphate injection, Magnesium sulfate
      injection, Azathioprine Tablets, Sulfasalazine Enteric-coated Tablets, Roxithromycin Soft
      Capsules, Clozapine Tablets, Desloratadine Tablets, Flupirtine Maleate, Fluvoxamine Maleate
      Tablets, Chlorphenamine Maleate Tablets, Enalapril Maleate Tablets, Meloxicam, Mesalazine
      Enteric-coated Tablets, Mirtazapine, Naproxen Tablets, Nikethamide Injection, Nimodipine
      Injection, Nitrendipine Tablets, Norfloxacin Capsules, Hydroxycarbamide Tablets, Artemisinin,
      Benzylpenicillin sodium, Hydrocortisone Injection, Citalopram Hydrobromide Tablets,
      Gentamicin, Colchicine Tablets, Doxifluridine Capsules, Deslanoside Injection, Ciprofloxacin
      Lactate and Sodium Chloride Injection, Celecoxib Capsules, Trifluoperazine, Tetrastigma
      hemsleyanum Diels et Gilg, Thalidomide Tablets, Sulpiride Tablets, Diclofenac Potassium
      Capsules, Clostridium butyricum TO-A, Dihydroartemisinin and Piperaquine Phosphate Tablets,
      Tetracycline Tablets, Lithium Carbonate Sustained-release Tablets, Tegafur Injection,
      Teicoplanin, Tinidazole and Sodium Chloride Injection, Cefoxitin, Ceftizoxime Sodium,
      Topiramate Tablets, Vancomycin, Tretinoin Tablets, Vemurafenib, Vitamin A, Vitamin B2
      Tablets, Vitamin D2 Injection, Cimetidine Tablets, Cimetidine Injection, Nifedipine Sustained
      Release Tablets, Nitroglycerin Injection, Isosorbide Dinitrate Injection, Valsartan
      Dispersible Tablets, Simvastatin Tablets, Thymalfasin, Ursodeoxycholic Acid, Folic acid
      calcium salt hydrate, Amitriptyline Hydrochloride Tablets, Bupropion Hydrochloride
      Sustained-Release Tablets, Amiodarone Hydrochloride Tablets, Ondansetron Hydrochloride
      Injection, Betahistine Hydrochloride Injection, Diphenhydramine Hydrochloride Injection,
      Bupropion Hydrochloride Injection Tablets, 3-Hydroxytyramine hydrochloride, Doxepin
      Hydrochloride, Flunayizine Hydrochloride Capsules, Prozac, Metoclopramide Dihydrochloride
      Injection, Arginine Hydrochloride Injection, Clindamycin Hydrochloride Injection, Raloxifene
      Hydrochloride Tablets, Ranitidine Hydrochloride Capsules, Lidocaine Hydrochloride Injection,
      Lobeline Hydrochloride Injection,, Chlorpromazine, Clomipramine Hydrochloride Tablets,
      Omeprazole Magnesium Enteric-coated Tablets, Mexiletine Hydrochloride Tablets, Paroxetine
      Hydrochloride Tablets, Procaine Hydrochloride for Injection, Trazodone Hydrochloride Tablets,
      Daunorubicin hydrochloride, Cyproheptadine Hydrochloride Tablets, Sertraline Hydrochloride
      Tablets, Tamsulosin Hydrochloride Sustained Release Capsules, Terazosin Hydrochloride
      Tablets, Verapamil Hydrochloride Tablets, Venlafaxine Hydrochloride Capsules, Raceanisodamine
      Hydrochloride Injection, Berberine Hydrochloride Tablets, Ethambutol Hydrochloride Tablets,
      Levofloxacin Hydrochloride for Injection, Itraconazole, Ivermectin,
      IPTG；Isopropyl-β-D-thiogalactoside, Isopropyl-beta-D-thiogalactopyranoside, Isoniazid
      Tablets, Indapamide Tablets, Indomethacin Enteric-coated Tablets, Amoxicillin Sodium and
      Clavulanate Potassium for injection, Azithromycin for Injection, Acyclovir for Injection,
      Ampicillin Sodium Injection, Omeprazole Sodium for Injection, Oxacillin Sodium for Injection,
      Biapenem for Injection, Benzathine Penicillin For Injection, Sodium Valproate for Injection,
      Ganciclovir, Fosfomycin Sodium for Injection, Asparaginase, Urokinase for Injection,
      Piperacillin Sodium for Injection, Artesunate for Injection, Sodium Nitroprusside, Diltiazem
      Hydrochloride for Injection, Recombinant Human Interferon gamma for Injection,
      Levobupivacaine, Levothyroxine Sodium Tablets, Levofloxacin Tablets

      Chemotherapy and target therapy drugs

      Aidi injection, Oxaliplatin for Injection, Epirubicin, Dacarbazine, Dabrafenib, mesylate,
      Dabratinib, Dasatinib Tablets, Sorafenib Tosylate Tablets, Doxorubicin, Docetaxel,
      5-Fluorouracil, Juyuansuan Tamoxifen, Cino bufotalin, Cyclophosphamide, Gefitinib (pure)
      powder, Gemcitabine hydrochloride, Methotrexate, Carboplatin, Capecitabine, Kanglaite
      Injection, Raltitrexed, Mabthera, Lobaplatin for Injection, Mitoxantrone, Nedaplatin,
      Mercaptopurine, Cisplatin, Mitomycin for Injection, Tacrolimus, Tegafur, Gimeracil and
      Oteracil Potassium, Temozolomide, Cetuximab Solution for Infusion, Lobaplatin for Injection,
      Mitoxantrone, Nedaplatin, Mercaptopurine, Cisplatin, Mitomycin for Injection, Tacrolimus,
      Tegafur, Gimeracil and Oteracil Potassium, Temozolomide, Cetuximab Solution for Infusion

      Chinese Herb Medicine

      English Name Latin Name Job's tears seed Coicis Semen, Japanese Ardisia Herb Japanese Ardisia
      Herb, White Hyacinth Bean Semen Dolichoris Album, Spreading Hedyotis Herb Hedyotis diffusa,
      Willowleaf Swallowwort Rhizome Rhizoma Cynanchi Stauntonii, Large head Atractylodes Rh
      Rhizoma Atractylodis Macrocephalae, Sessile Stemona Root Japanese Stemona Root, Lily Lilium
      brownii var. viridulum, Seman Platycladi Seman, Isatis root Isatis tinctoria, Herba Lobeliae
      Chinensis Lobelia chinensis Lour, Pinellia ternata Pinellia ternata (Thunb.) Breit,
      Scutellaria barbata Scutellaria barbata, CoasiaI GIehnia Root Glehnia littoralis, Fritillary
      fritillary, Ficus pumila Linn Ficus pumila, Seed-coat of Hyacinth Dolichos, Areca Seed, Betel
      Nut Semen Arecae, Malaytea Scurfpea Fruit Fructus Psoraleae, Semen raphani , Silkworm shit
      Faeces Bombycis, Siberian Cocklour Fruit Fructus Xanthii, Rhizome of Swordlike Atractylodes
      Rhizoma Atractylodis, Root of Chinese Thorowax Radix Bupleuri, Radices paeoniae rubra
      Paeoniae Rubra Radix, Dan - shen Root Salviae Miltiorrhizae Radix, Tree Peony Root - bark
      Moutan Radicis Cortex, Chinese Goldthread Rhizome Coptidis Rhizoma, Skunk Bugbane Rhizome
      Cimicifugae Foetidae Rhizoma, Coix seed Semen Coicis Szechwan Chinaberry Fruit Fructus Meliae
      Toosendan, Radix Cyathulate Radix Cyathulae, Common Andrographis Herb Herba Andrographis,
      Radix et Caulis Acanthopanacis Senticosi Radix et Caulis Acanthopanacis Senticosi, Japanese
      Thistle Herbor Root Herba seu Radix Cirsii Japonici, Indigowoad Leaf, Leaf of Indigowoad
      Folium Isatidis, Danshen Root, Root of Dan-shen Salviae Miltiorrhizae Radix et Rhizoma, Root
      of Pilose Asiabell Radix Codonopsis, Fructus Oryzae Germinatus Fructus Oryzae Germinatus,
      Humifuse Euphorbia Herb Herba Euphorbiae Humifusae, Chinese Waxgourd Peel Exocarpium
      Benincasae, Waxgourd seed Semen Benincasae, Rabdosia rubesens,hamst Rabdosia rubescens,
      Rhioxma Curcumae Aeruginosae Rhizoma Curcumae, Divaricate Saposhnikovia RootRadix
      Saposhnikoviae, Indian Buead Poria, Pine among the Indian Bread, Blighted Wheat Fructus
      Tritici Levis, Radix Glycyrrhizae Radix Glycyrrhizae, Toad skin, Perfoliate Knotweed Herb
      Polygonum perfoliatum, Ligusticum sinense Oliv Rhizoma Ligustici, Barbary Wolfberry Fruit
      Fructus Lycii, Herba Pogostemonis Herba Pogostemonis, Sargassum Sargassum, Yerbadetajo Herb
      Herba Ecliptae Eclipta prostrala, Terminalia chebula Retz, Taxus chinensis Taxus chinensis
      (Pilger) Rehd, Flos Carthami Flos Carthami, Root of Kirilow Rhodiola Herba Rhodiolae,
      Figwortflower Picrorhiza Rhizome Rhizoma Picrorhizae, Polygonum cuspidatum Rhizoma Polygoni
      Cuspidati, Pricklyash Peel Pericarpium Zanthoxyli, Talcum Talcum, Exocarpium Citri Grandis
      Exocarpium Citri Grandis, Phellodendron Chinese Schneid Cortex Phellodendri, Manyflower
      Solomonseal Rhizome Rhizoma Polygonati, Radix Astragali Radix Astragali seu Hedysari, Radix
      Scutellariae, Flos Celosiae Cristae Flos Celosiae Cristatae, Suberect Spatholobus Stem Caulis
      Spatholobi, Rhizoma Curcumae Longae Rhizoma Curcumae Longae, Christina Loosestrife HerbHerba
      Lysimachiae, Japanese Honysuckle Flower Bud Flos Lonicerae, Cherokee Rose Fruit Fructus Rosae
      Laevigatae, Chrysanthemum flower Flos Chrysanthemi, Spikemoss Herba Selaginellae, Cassia seed
      Semen Cassiae, Lightyellow sophora root Radix Sophorae Flavescentis, Kelp Laminariae Thallus,
      Semen Litchi Semen Litchi, Chinese trumpet creeper Campsis grandiflora, Diverse Wormwood Herb
      Herba Artemisiae Anomalae, Radix Gentianae Gentiana Scabra Bunge, Reed Rhizome Stemmacanthae
      Unifori Radix, Caulis Trachelospermi Trachelospermi Jasminoidis Caulis, Lv Bean Spermodermis
      Phaseoli Radiati, European Verbena Herb Herba Verbenae Officinalis, Herba Portulacae
      Portulaca oleracea L, Radix Ophiopogonis Ophiopogonis Radix, Fructus Hordei Germinatus Hordei
      Germinatus Fructus, Concha Ostreae Concha Ostreae, Costustoot, Common Vladimiria Root
      Aucklandiae Radix, Fructus Ligustri Lucidi Ligustri Lucidi Fructus, Fortune Eupatorium Herb
      Eupatorii Fortunei Herba, Folium Eriobotryae Eriobotryae Japonicae Folium, Dandelion Herba
      Taraxaci, Flower of Shepherdspurse Capsella bursa-pastoris (L.)Medic), Rhizoma Homalomenae
      Rhizoma Homalomenae, Gordon Enryale Seed Euryales Semen, Radix Gentinae Gentianae
      Macrophyllae Radix, Cortex Fraxini Fraxini Cortex, Caulis SinomeniiI Caulis Sinomenii, Semen
      Celosiae Celosiae Argenteae Semen, Herba Dianthi Dianthi Superbi Herba, Caulis Lonicerae
      Lonicerae Caulis, Cortex CinnamoniCinnamomi Cassiae Cortex, Rhizoma Srarganii Rhizoma
      Sparganii, Sanchi Panax pseudo-ginseng var, Radix tetrastigme Tetrastigma hemsleyanum Diels
      et Gilg, Folium Mori Mori Folium, Chinese yam Dioscorea opposite, Amorphophallus rivieri
      Durieu Amorphophallus rivieri Durieu, Snake venom, Snake Slough Serpentis Periostracum,
      Rhizoma Belamcandae rhizoma belamcandae, Largetrifoliolious Bugbane RhizmomeRhizoma
      Cimicifugae, Radix Sanguisorbae SanguisorbaofficinalisL, Eucommia ulmoides Oliver Eucommia
      ulmoides, Rhizoma Zingiberis RecensZingiber officinale Roscoe, Salvia chinensis Benth Salvia
      chinensis Benth, Folium Photiniae Photinia serrulata Lindl, Lignum Sappan Lignum Sappan,
      Semen Persicae Semen Persicae, Radix Asparagi Radix Asparagi, Root of Nakedcaule Groundsel
      Radix Semiaquilegiae, Root of Common carpesium Herba Carpesii Abrotanoidis, Semen lepidii
      Semen Lepidii, Herb of Tuberculate Speranskia Phryma leptostachya L. subsp. asiatica (Hara),
      China Dodder Semen Cuscutae, Semen Vaccariae Semen Vaccariae, Herb of Coffee Senna Cassia
      occidentalis Linn, Fructus Mume Fructus Mume, Root of Combined Spicebush Radix Linderae, Fig
      Ficus carica Linn, Medicinal Evodia Fruit Evodia rutaecarpa (Juss.) Benth, Chinese Gall,
      Chinese Nut-gall Rhus chinensis Mill, Sessileflower Acanthopanax Bark Cortex Acanthopanax
      Radicis, All-grass of Bluecalyx Japanese Rabdosia, Fructus Foeniculi Fructus Foeniculi,
      Common Cephalanoplos Herb Cirsium setosum (Willd.) MB, Flos Magnoliae Flos Magnoliae,
      Paniculate Swallowwort Root Cynanchum paniculatum (Bunge) Kitagawa, Linseed,seed of Flax
      Linseed seed of Flax, Fructus Alpiniae Oxyphyllae Alpinia oxyphylla Miq, Job's tears seed
      Semen Coicis, Herba Artemisiae Scopariae ArtemisiacapillarisThunb, Folium Ginkgo
      Ginkgobiloba, Heartleaf Houttuymia Herb Houttuynia cordata Thunb, Turmeric Root-tuber Radix
      Curcumae, Akebia Fruit Foreknowledge, Hiraute Shiny Bugleweek Herb Aconitum gymnandrum Maxim,
      Rhizoma Paridis RhizomaParidis, Polyporus Polyporus, Root of Sinkiang Arnebia Lithospermum
      erythrorhizon Sieb. et Zucc, Herba Violae Viola yedoensis Makino, Fluoritum Fluoritum Caulis
      Perillae Perilla frutescens （L.）Britton
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This single center, open-label, single arm, non-randomized study is designed to evaluate safety, progression-free survival(PFS),overall survival (OS), objective response rate (OPR), and disease control rate (DCR) of chemotherapy or target therapy or chinese medicine based on the Alphacait screening system in subjects with advanced malignant tumor.
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival(PFS)
time frame: 36 months
description: Progression-free survival (PFS) is defined as the time from assignment in the trial to disease progression or death from any cause.
measure: Overall survival(OS)
time frame: 36 months
description: Defined as the time from assignment to death from any cause.
measure: Overall response rate (ORR)
time frame: 36 months
description: Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy
measure: Disease control rate(DCR)
time frame: 36 months
description: Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response or stable disease to therapy
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 36 months
description: Drug-related adverse reactions must be recorded, mainly in the following：myelosuppression including neutropenia, anemia and thrombocytopenia;Cardiac toxicity; muscle fatigue, pain, imbalance; Oral ulcers: the patient's gums, cheeks, throat and tongue are prone to ulcers;nausea, vomiting, constipation or diarrhea;hair loss;skin discomfort;hormonal fluctuations, sexual dysfunction, infertility; damage of the kidney;anxiety and depression.
measure: Biomarkers
time frame: 36months
description: Expectations of exploratory markers for this study include the status of exploratory biomarkers associated with immunohistochemistry (IHC) or quantitative reverse transcription polymerase chain reaction (qRT-PCR), a new generation sequencing method (NGS), Nanostring technique and / or other methods to evaluate archived and/or newly acquired tumor tissue, as well as its association with disease status and/or (Including but not limited to somatic mutations and other exploratory markers) according to qRT-PCR and NGS techniques, and to evaluate the relationship between the therapeutic response, the status of the biomarker during exploratory treatment and during treatment, and the evaluation of plasma, serum or whole blood samples (including but not limited to somatic mutations and other exploratory markers) The association of the above markers with disease status and / or therapeutic response.
arm group label: Alphacait-guided therapy
arm group type: Experimental
description: Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines until the patient progresses, intolerant, the patient withdrawn or the investigator determines that the medication must be discontinued.
intervention type: Drug
intervention name: Non Chemotherapy
description: Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.
arm group label: Alphacait-guided therapy
intervention type: Drug
intervention name: Chemotherapy and target therapy
description: Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.
arm group label: Alphacait-guided therapy
intervention type: Drug
intervention name: Chinese herb medicine
description: Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.
arm group label: Alphacait-guided therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Haizhou Lou, MD
role: Principal Investigator
affiliation: Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine
last name: Linghua Zhu, MD
role: Principal Investigator
affiliation: Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine
last name: Enguo Chen, MD
role: Principal Investigator
affiliation: Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine
last name: Bin Li, MD
phone: 86-137-50766911
email: yanfangren1019@gmail.com
last name: Haizhou Lou, MD
phone: 86-571-86006926
email: louhz09@aliyun.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
sharing ipd: Yes
ipd description: Through publication after study completion
ipd info type: Study Protocol
ipd time frame: 12/31/2018