<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/NCT03230708</url>
  </required_header>
  <id_info>
    <org_study_id>NP-FS-002</org_study_id>
    <nct_id>NCT03230708</nct_id>
  </id_info>
  <brief_title>Clinical Study of Autologous Erythrocytes Derived MPs Packaging MTX Peritoneal Perfusion to Treat Malignant Ascites</brief_title>
  <official_title>A Phase I/II Clinical Trial Study on Autologous Erythrocytes Derived Microparticles Packaging Methotrexate Peritoneal Perfusion in the Treatment of Malignant Ascites</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hui ting Xu，MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hubei Cancer Hospital</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>
      This study makes an observation over the objective response rate of autologous erythrocytes&#xD;
      derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy&#xD;
      combination in the treatment of malignant ascites. All the participants will randomly receive&#xD;
      the treatment of autologous erythrocytes derived microparticles packaging methotrexate&#xD;
      peritoneal perfusion and systemic therapy combination or convention drugs peritoneal&#xD;
      perfusion and systemic therapy combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a drug carrier, erythrocytes have their own advantages, such as high biocompatibility,&#xD;
      high immune compatibility, simple structure and easy access. In this study, microparticles&#xD;
      released from erythrocytes are used as the carrier of chemotherapy drugs and effectively kill&#xD;
      tumor cells in malignant ascites. These microparticles can easily reach the tumor site and&#xD;
      bring the drug into tumor cells, which can overcome the two main problems in normal&#xD;
      chemotherapy: damage to normal cells and drug resistance of tumor cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ORR, Objective Response Rate</measure>
    <time_frame>From assignment of the first subject to 2 months later after the last participant is recruited.</time_frame>
    <description>The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DCR, Disease Control Rate</measure>
    <time_frame>From assignment of the first subject to 2 months later after the last participant is recruited.</time_frame>
    <description>DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Malignant Ascites</condition>
  <arm_group>
    <arm_group_label>Erythrocytes derived MPs containing MTX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Suspension of erythrocytes derived MPs containing MTX, qd×6, 6 units MPs a time , Two courses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>convention drugs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chemotherapeutic drugs, biologicals or traditional Chinese medicine.Dosage form, dosage, frequency and duration according to respective medicine instructions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Erythrocytes derived MPs containing MTX</intervention_name>
    <description>General conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX</description>
    <arm_group_label>Erythrocytes derived MPs containing MTX</arm_group_label>
    <other_name>Systemic therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>convention drugs</intervention_name>
    <description>according to usage method of drugs</description>
    <arm_group_label>convention drugs</arm_group_label>
    <other_name>Systemic therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 and ≤ 80 years of age&#xD;
&#xD;
          -  Histological confirmed gastric cancer, colorectal cancer, or ovarian cancer, tumor&#xD;
             cells were detected by exfoliative cytology of peritoneal effusion, refractory or&#xD;
             recurrent ascites of ovarian cancer were required, other kinds of cancer were not&#xD;
             limited&#xD;
&#xD;
          -  Vital signs were stable, Karnofsky ≥ 70, life expectancy of more than 3 months&#xD;
&#xD;
          -  The hematopoietic function of bone marrow was normal without bleeding tendency (INR &lt;&#xD;
             1.5), blood routine examination: HGB ≥ 90 g/L, WBC &gt; 4.0 × 10^9/L (NEU ≥ 1.5 ×&#xD;
             10^9/L), PLT ≥ 80 × 10^9/L&#xD;
&#xD;
          -  Liver function: STB ≤ 1.5 ULN, AST and ALT≤ 2.5 ULN (if the abnormity of liver&#xD;
             function was mainly caused by tumor invasion, AST and ALT ≤ 5 ULN), ALP ≤ 1.5 ULN&#xD;
&#xD;
          -  Renal function: BUN and Cr ≤ 1.5 ULN, CCr ≥ 50mL/min&#xD;
&#xD;
          -  ECG and blood glucose level were normal&#xD;
&#xD;
          -  Patients or family members agreed to participate in the study and signed informed&#xD;
             consent&#xD;
&#xD;
          -  No other serious heart and lung disease, etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Allergic constitution and multi-drug allergy&#xD;
&#xD;
          -  Serious heart, lung, liver and kidney dysfunction, decompensated heart, lung, kidney,&#xD;
             liver and other major organs dysfunction or failure, poor blood glucose control,&#xD;
             chemotherapy intolerance, combined intestinal obstruction&#xD;
&#xD;
          -  Concurrent severe infection&#xD;
&#xD;
          -  HIV positive, HBsAg and HBV DNA copy number positive (quantitative detection ≥ 1000&#xD;
             cps/mL), chronic hepatitis C blood screening positive (HCV antibody positive)&#xD;
&#xD;
          -  Cognitive impairment or poor chemotherapy compliance determined by investigator&#xD;
&#xD;
          -  Less than 4 weeks from the last clinical trial&#xD;
&#xD;
          -  Unsuitable for clinical trials determined by investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan li Nie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hu bei CH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hui ting Xu</last_name>
    <phone>15307176219</phone>
    <phone_ext>86</phone_ext>
    <email>2891533@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hong li Xu</last_name>
    <phone>13554458191</phone>
    <email>xu2010ky@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hui ting Xu</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>027</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui ting Xu, MD</last_name>
      <phone>15307176219</phone>
      <phone_ext>86</phone_ext>
      <email>2891533@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hubei Cancer Hospital</investigator_affiliation>
    <investigator_full_name>Hui ting Xu，MD</investigator_full_name>
    <investigator_title>Deputy Chief Physician</investigator_title>
  </responsible_party>
  <keyword>Microparticles</keyword>
  <keyword>Erythrocytes</keyword>
  <keyword>Methotrexate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascites</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/NCT03230708
org study id: NP-FS-002
nct id: NCT03230708
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study makes an observation over the objective response rate of autologous erythrocytes
      derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy
      combination in the treatment of malignant ascites. All the participants will randomly receive
      the treatment of autologous erythrocytes derived microparticles packaging methotrexate
      peritoneal perfusion and systemic therapy combination or convention drugs peritoneal
      perfusion and systemic therapy combination.
As a drug carrier, erythrocytes have their own advantages, such as high biocompatibility,
      high immune compatibility, simple structure and easy access. In this study, microparticles
      released from erythrocytes are used as the carrier of chemotherapy drugs and effectively kill
      tumor cells in malignant ascites. These microparticles can easily reach the tumor site and
      bring the drug into tumor cells, which can overcome the two main problems in normal
      chemotherapy: damage to normal cells and drug resistance of tumor cells.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ORR, Objective Response Rate
time frame: From assignment of the first subject to 2 months later after the last participant is recruited.
description: The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
measure: DCR, Disease Control Rate
time frame: From assignment of the first subject to 2 months later after the last participant is recruited.
description: DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)
arm group label: Erythrocytes derived MPs containing MTX
arm group type: Experimental
description: Suspension of erythrocytes derived MPs containing MTX, qd×6, 6 units MPs a time , Two courses.
arm group label: convention drugs
arm group type: Active Comparator
description: Chemotherapeutic drugs, biologicals or traditional Chinese medicine.Dosage form, dosage, frequency and duration according to respective medicine instructions.
intervention type: Other
intervention name: Erythrocytes derived MPs containing MTX
description: General conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX
arm group label: Erythrocytes derived MPs containing MTX
other name: Systemic therapy
intervention type: Drug
intervention name: convention drugs
description: according to usage method of drugs
arm group label: convention drugs
other name: Systemic therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yan li Nie, MD
role: Principal Investigator
affiliation: Hu bei CH
last name: Hui ting Xu
phone: 15307176219
phone ext: 86
email: 2891533@qq.com
last name: Hong li Xu
phone: 13554458191
email: xu2010ky@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Hubei Cancer Hospital
investigator full name: Hui ting Xu，MD
investigator title: Deputy Chief Physician
mesh term: Ascites
sharing ipd: No