<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/NCT03258034</url>
  </required_header>
  <id_info>
    <org_study_id>Ahead-G328</org_study_id>
    <nct_id>NCT03258034</nct_id>
  </id_info>
  <brief_title>A Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer</brief_title>
  <official_title>Phase II Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Zhejiang Chinese Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First Affiliated Hospital of Zhejiang Chinese Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prognosis of Extensive lymph nodes metastatic(ELM) gastric cancer is poor. Chemotherapy&#xD;
      occasionally converts it to a resectable cancer. Previous studies showed patients with ELM&#xD;
      gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative&#xD;
      surgery. The key of conversion therapy of ELMGC is the high response rate. Apatinib, a novel&#xD;
      targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the&#xD;
      patients with GC. On the basis of our previous Ahead-G325 study, The purpose of this study is&#xD;
      to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the&#xD;
      conversion therapys of ELM gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will apply SPA regimen for coversional therapy to abtain high response&#xD;
      rate. Paclitaxel：150 mg/m2 i.v.3h , given on the first day. Apatinib, oral ,initial dose&#xD;
      :425mg, QD, after meal ( try to take the medicine at the same time of the day ). Dose&#xD;
      adjustment: Down-regulate the dosage to 250 mg per day at the first time. If the patient&#xD;
      totally recovers from the toxic reaction after the regulation, we could up-regulate the&#xD;
      dosage back to the former level. If the downregulation occurs again according to the protocol&#xD;
      , then the up-regulation will be forbidden.&#xD;
&#xD;
      S-1 dosage: According to the body surface area, the initial dosage of S-1 is decided by the&#xD;
      following criteria. Take the medicine twice daily (after breakfast and supper) for 2 weeks,&#xD;
      then suspend for 1 week. Preventive medication: To prevent serious allergic reaction of&#xD;
      Paclitaxel, preventive medication should be given in advance. We usually give dexamethasone&#xD;
      20mg orally 12 and 6 hours before the Paclitaxel, and diphenhydramine (or something&#xD;
      analogous) 50 mg, cimetidine 300mg (or ranitidine 50mg) I.V. 30-60 minutes before the&#xD;
      Paclitaxel. Repeat the therapeutic schedule every 3 weeks. 3-4 cycles of neoadjuvant&#xD;
      chemotherapy before surgery, stop Apatinib in the last cycle.4 cycles of adjuvant&#xD;
      chemotherapy including S-1 and Apatinib 4 to 6 weeks after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">August 24, 2017</start_date>
  <completion_date type="Anticipated">October 22, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 22, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3 year OS</measure>
    <time_frame>3 years</time_frame>
    <description>The overall survival time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>radical resection rate</measure>
    <time_frame>4 months</time_frame>
    <description>the radical resection rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3 year DFS</measure>
    <time_frame>3 years</time_frame>
    <description>the diesease free survival time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5 year OS</measure>
    <time_frame>5 years</time_frame>
    <description>The overall survival time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>7months</time_frame>
    <description>number and degree of adverse events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Conversion treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>after 3-4 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPA</intervention_name>
    <description>S1/Paclitaxel chemotherapy plus Apatinib S1:60mg twice daily(after the breakfast and supper) for two weeks, and then suspend for one week Paclitaxel:150mg/m2,iv, 3h, at day1 Apatinib:425mg once daily</description>
    <arm_group_label>Conversion treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ELM gastric cancer as proven histologically under following condition: unable radical&#xD;
             excision due to the abdominal aorta a2-b1 or extensive lymph nodes metastatic,&#xD;
&#xD;
          -  Definitely diagnosed as above stage of gastric cancer before operation via CT of MRI,&#xD;
             ultrasonic endoscopy, PET-CT, or through the laparoscopic exploration if necessary&#xD;
&#xD;
          -  Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)&#xD;
&#xD;
          -  Negative HER-2 state&#xD;
&#xD;
          -  ECOG(Eastern Cooperative Oncology Group): 0~2&#xD;
&#xD;
          -  Age: 18~70 years old- survival time &gt; 3monts&#xD;
&#xD;
          -  Normal hemodynamic indices before the recruitment(including blood cell count and&#xD;
             liver/kidney function ). For example: WBC&gt;4.0*109/ L, NE&gt;1.5*109/L, PLT&gt;100*109/L,&#xD;
             BIL&lt;1.5 times of upper limit of normal reference value, ALT and AST&lt;2.5 times of upper&#xD;
             limit of normal reference value, and CRE&lt;1.2mg/dl&#xD;
&#xD;
          -  Good cardiac function before the recruitment, no seizure of myocardial infarction in&#xD;
             past half years, and controllable hypertension and other coronary heart disease&#xD;
&#xD;
          -  Not concomitant with other uncontrollable benign disease before the recruitment(e.g.&#xD;
             the infection in the kidney, lung and liver)&#xD;
&#xD;
          -  Not participating in other clinical trials before and during the treatment&#xD;
&#xD;
          -  Signed the Informed Consent Form&#xD;
&#xD;
          -  No peritoneal metastatic and CY0 in 28 days by laparoscopic exploration&#xD;
&#xD;
          -  Non-gastric stump cancer&#xD;
&#xD;
          -  No esophagus infiltrating or infiltrating less than 3cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distal metastasis to Mediastinal lymph node,liver ,peritoneal,pleural effusion&#xD;
             ,ascites,above 16a2-b1 and others&#xD;
&#xD;
          -  Severe mental illness&#xD;
&#xD;
          -  Her-2 positive, desire for hercptin treatment&#xD;
&#xD;
          -  Ever administrated with other drugs(including TCM drugs) before the recruitment, or no&#xD;
             guarantee of progress according to the study requirement after recruitment&#xD;
&#xD;
          -  Allergy to the drugs in this protocol&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Women at childbearing age and of pregnancy desire during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiangdong Cheng, MD</last_name>
    <role>Study Director</role>
    <affiliation>The First Affiliated Hospital of Zhejiang Chinese Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The first affiliated hospital of zhejiang chinese medical university</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Conversion therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03258034
org study id: Ahead-G328
nct id: NCT03258034
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The prognosis of Extensive lymph nodes metastatic(ELM) gastric cancer is poor. Chemotherapy
      occasionally converts it to a resectable cancer. Previous studies showed patients with ELM
      gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative
      surgery. The key of conversion therapy of ELMGC is the high response rate. Apatinib, a novel
      targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the
      patients with GC. On the basis of our previous Ahead-G325 study, The purpose of this study is
      to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the
      conversion therapys of ELM gastric cancer.
The investigators will apply SPA regimen for coversional therapy to abtain high response
      rate. Paclitaxel：150 mg/m2 i.v.3h , given on the first day. Apatinib, oral ,initial dose
      :425mg, QD, after meal ( try to take the medicine at the same time of the day ). Dose
      adjustment: Down-regulate the dosage to 250 mg per day at the first time. If the patient
      totally recovers from the toxic reaction after the regulation, we could up-regulate the
      dosage back to the former level. If the downregulation occurs again according to the protocol
      , then the up-regulation will be forbidden.

      S-1 dosage: According to the body surface area, the initial dosage of S-1 is decided by the
      following criteria. Take the medicine twice daily (after breakfast and supper) for 2 weeks,
      then suspend for 1 week. Preventive medication: To prevent serious allergic reaction of
      Paclitaxel, preventive medication should be given in advance. We usually give dexamethasone
      20mg orally 12 and 6 hours before the Paclitaxel, and diphenhydramine (or something
      analogous) 50 mg, cimetidine 300mg (or ranitidine 50mg) I.V. 30-60 minutes before the
      Paclitaxel. Repeat the therapeutic schedule every 3 weeks. 3-4 cycles of neoadjuvant
      chemotherapy before surgery, stop Apatinib in the last cycle.4 cycles of adjuvant
      chemotherapy including S-1 and Apatinib 4 to 6 weeks after surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3 year OS
time frame: 3 years
description: The overall survival time
measure: radical resection rate
time frame: 4 months
description: the radical resection rates
measure: 3 year DFS
time frame: 3 years
description: the diesease free survival time
measure: 5 year OS
time frame: 5 years
description: The overall survival time
measure: adverse events
time frame: 7months
description: number and degree of adverse events
arm group label: Conversion treatment
arm group type: Experimental
description: after 3-4 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent.
intervention type: Drug
intervention name: SPA
description: S1/Paclitaxel chemotherapy plus Apatinib S1:60mg twice daily(after the breakfast and supper) for two weeks, and then suspend for one week Paclitaxel:150mg/m2,iv, 3h, at day1 Apatinib:425mg once daily
arm group label: Conversion treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiangdong Cheng, MD
role: Study Director
affiliation: The First Affiliated Hospital of Zhejiang Chinese Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Stomach Neoplasms
sharing ipd: No