<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/NCT04410887</url>
  </required_header>
  <id_info>
    <org_study_id>DRAGON VI: PISOXO Phase I</org_study_id>
    <nct_id>NCT04410887</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Chemotherapy With PISOXO for Locally-invaded-gastric Cancer (LIGC)</brief_title>
  <official_title>Neoadjuvant Chemotherapy With Pressurized Intra Peritoneal Aerosol Chemotherapy(PIPAC) Plus SOX Plus Olaparib (PISOXO) for Locally-invaded-gastric Cancer (LIGC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</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>
      The main purpose of this study is to compare the safety and efficacy of PIPAC+SOX+OLAPARIB&#xD;
      for locally-invaded-gastric cancer (LIGC) patients in China. To obtain preliminary results&#xD;
      for designing a new phase II/III randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peritoneal metastases is the main cause of relapse and death after surgery in patients with&#xD;
      serosa positive or locally-invaded-gastric cancer (LIGC). Recent researches showed that PIPAC&#xD;
      and Olaparib are effective to control peritoneal metastases in different malignant diseases&#xD;
      but it has not been tested for gastric cancer patients. The main purpose of this study is to&#xD;
      compare the safety and efficacy of PIPAC+SOX+OLAPARIB for locally-invaded-gastric cancer&#xD;
      (LIGC) patients in China. To obtain preliminary results for designing a new phase II/III&#xD;
      randomized controlled trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2020</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>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>Pathological response rate</measure>
    <time_frame>Upto three months after curative resection of the primary tumor</time_frame>
    <description>Total percentage of patients with pathological complete or sub-total tumor regression (TRG1a+1b) in the primary tumour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Five years</time_frame>
    <description>Overall survival (OS): Time from randomization to death from relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival (DFS)</measure>
    <time_frame>Three years</time_frame>
    <description>Time from randomization to relapse of disease</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Stomach Cancer</condition>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>PISOXO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>st cycle of PIPAC during 1st laparoscopic exploration Three cycles of SOX&#xD;
nd cycle of PIPAC during 2nd laparoscopic exploration Surgery Three cycles of SOX +/-OLAPARIB&#xD;
PIPAC Intraperitoneal chemotherapy for PIPAC is Docetaxel Neoadjuvant Chemotherapy Patients will receive three cycles of a standard dose of Tegafur gimeracil oteracil potassium capsule (TGO) plus oxaliplatin (SOX) +Olaparib prior to curative gastrectomy.&#xD;
Adjuvant chemotherapy Three cycles of SOX +/- OLAPARIB will be given as postoperative chemotherapy.&#xD;
Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule (TGO) 80mg/M2 oral (twice daily) Repeated every 21st day OLAPARIB Day 1-14: Olaparib 300mg oral twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PIPAC+SOX+OLAPARIB</intervention_name>
    <description>SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day OLAPARIB Day 1-14: Olaparib 300mg BID PO</description>
    <arm_group_label>PISOXO</arm_group_label>
    <other_name>Chemotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric&#xD;
             junction.&#xD;
&#xD;
          -  Clinical stage: cTNM: T4b and or N0-3 M0&#xD;
&#xD;
          -  Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to&#xD;
             symptomatic but in bed less than half the day)&#xD;
&#xD;
          -  Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate&#xD;
             renal, hepatic, hematologic, and pulmonary function.&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e.&#xD;
             uncontrolled cardiac disease, or other clinically significant uncontrolled&#xD;
             comorbidities, unable to undergo general anesthesia&#xD;
&#xD;
          -  Distant metastases&#xD;
&#xD;
          -  Locally advanced inoperable disease (Clinical assessment)&#xD;
&#xD;
          -  Relapse of gastric cancer&#xD;
&#xD;
          -  Prior chemo or radiotherapy&#xD;
&#xD;
          -  Inclusion in another clinical trial&#xD;
&#xD;
          -  Known contraindications or hypersensitivity for planned chemotherapy&#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>Birendra K Sah, PH D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chen Li, PH D</last_name>
    <role>Study Director</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhenggang Zhu, PH D</last_name>
    <role>Study Chair</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Birendra K Sah, Ph D</last_name>
    <phone>0086-13817516354</phone>
    <email>rjsurgeon@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhenggang Zhu, Ph D</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ruijin Hospital Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>BIRENDRA KUMAR SAH</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olaparib</mesh_term>
  </intervention_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/NCT04410887
org study id: DRAGON VI: PISOXO Phase I
nct id: NCT04410887
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to compare the safety and efficacy of PIPAC+SOX+OLAPARIB
      for locally-invaded-gastric cancer (LIGC) patients in China. To obtain preliminary results
      for designing a new phase II/III randomized controlled trial.
Peritoneal metastases is the main cause of relapse and death after surgery in patients with
      serosa positive or locally-invaded-gastric cancer (LIGC). Recent researches showed that PIPAC
      and Olaparib are effective to control peritoneal metastases in different malignant diseases
      but it has not been tested for gastric cancer patients. The main purpose of this study is to
      compare the safety and efficacy of PIPAC+SOX+OLAPARIB for locally-invaded-gastric cancer
      (LIGC) patients in China. To obtain preliminary results for designing a new phase II/III
      randomized controlled trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathological response rate
time frame: Upto three months after curative resection of the primary tumor
description: Total percentage of patients with pathological complete or sub-total tumor regression (TRG1a+1b) in the primary tumour
measure: Overall survival (OS)
time frame: Five years
description: Overall survival (OS): Time from randomization to death from relapse
measure: Disease free survival (DFS)
time frame: Three years
description: Time from randomization to relapse of disease
arm group label: PISOXO
arm group type: Experimental
description: st cycle of PIPAC during 1st laparoscopic exploration Three cycles of SOX
nd cycle of PIPAC during 2nd laparoscopic exploration Surgery Three cycles of SOX +/-OLAPARIB
PIPAC Intraperitoneal chemotherapy for PIPAC is Docetaxel Neoadjuvant Chemotherapy Patients will receive three cycles of a standard dose of Tegafur gimeracil oteracil potassium capsule (TGO) plus oxaliplatin (SOX) +Olaparib prior to curative gastrectomy.
Adjuvant chemotherapy Three cycles of SOX +/- OLAPARIB will be given as postoperative chemotherapy.
Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule (TGO) 80mg/M2 oral (twice daily) Repeated every 21st day OLAPARIB Day 1-14: Olaparib 300mg oral twice a day
intervention type: Drug
intervention name: PIPAC+SOX+OLAPARIB
description: SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day OLAPARIB Day 1-14: Olaparib 300mg BID PO
arm group label: PISOXO
other name: Chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Birendra K Sah, PH D
role: Principal Investigator
affiliation: Ruijin Hospital
last name: Chen Li, PH D
role: Study Director
affiliation: Ruijin Hospital
last name: Zhenggang Zhu, PH D
role: Study Chair
affiliation: Ruijin Hospital
last name: Birendra K Sah, Ph D
phone: 0086-13817516354
email: rjsurgeon@hotmail.com
last name: Zhenggang Zhu, Ph D
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: BIRENDRA KUMAR SAH
investigator title: Principal investigator
mesh term: Stomach Neoplasms
mesh term: Olaparib
sharing ipd: No