<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/NCT03822130</url>
  </required_header>
  <id_info>
    <org_study_id>IR2018001142</org_study_id>
    <nct_id>NCT03822130</nct_id>
  </id_info>
  <brief_title>Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer</brief_title>
  <official_title>A Randomized Controlled Trial for Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate and Systemic Chemotherapy for Unresectable Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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 project intends to compare the clinical effects and side effects of three kinds of&#xD;
      treatment methods in the treatment of unresectable gastric cancer by intra-arterial catheter&#xD;
      infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy. It is clear&#xD;
      that intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate is not&#xD;
      suitable for the treatment of unresectable gastric cancer. The clinical practice value of&#xD;
      resection of gastric cancer can provide high quality evidence-based medical basis for the&#xD;
      treatment guidelines of advanced gastric cancer, and explore a new clinical technology with&#xD;
      exact curative effect and higher safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Early Phase 1</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>Successful conversion rate of operation</measure>
    <time_frame>42 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>42 days</time_frame>
    <description>Objective Response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
    <description>progression-free survival</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Successful Conversion Rate of Operation</condition>
  <condition>Unresectable Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Systemic Chemotherapy + Oral Chemotherapy Group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arterial catheter infusion chemotherapy plus oral chemotherapy group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Arterial catheter infusion chemotherapy</intervention_name>
    <description>Arterial catheter infusion chemotherapy</description>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Bicarbonate</intervention_name>
    <description>Arterial catheter infusion Sodium Bicarbonate</description>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Systemic Chemotherapy</intervention_name>
    <description>Systemic Chemotherapy</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Chemotherapy</intervention_name>
    <description>Oral Chemotherapy</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged 18 to 75 years;&#xD;
&#xD;
          2. Ultrasound gastroscopy or imaging (CT) can diagnose potentially unresectable gastric&#xD;
             cancer (T4a-bN2-3M0) with indications of neoadjuvant chemotherapy or transformation&#xD;
             therapy;&#xD;
&#xD;
          3. Pathological diagnosis of gastric cancer;&#xD;
&#xD;
          4. No contraindication of chemotherapy;&#xD;
&#xD;
          5. Patients who did not undergo chemotherapy or were diagnosed for the first time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those who fail to comply with the requirements of the trial, obviously violate this&#xD;
             regimen, or change to other regimens in the course of treatment;&#xD;
&#xD;
          2. The life expectancy of patients with extensive systemic metastasis is less than 3&#xD;
             months;&#xD;
&#xD;
          3. Leukocyte count is less than 2*109/L and platelet count is less than 75*10^9/L;&#xD;
&#xD;
          4. Severe heart, liver and kidney diseases, unable to tolerate chemotherapy;&#xD;
&#xD;
          5. Patients without gastric cancer complications such as massive gastrointestinal&#xD;
             bleeding and perforation need to be treated in emergency department;&#xD;
&#xD;
          6. Patients with distant metastasis (excluding group 16 lymph node metastasis);&#xD;
&#xD;
          7. Patients with other tumors, with a history of malignant tumors (excluding early&#xD;
             primary cancers);&#xD;
&#xD;
          8. The patient himself asked to withdraw from the trial;&#xD;
&#xD;
          9. Researchers believe that patients are not suitable for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ming Chao</last_name>
    <phone>+86 13957139239</phone>
    <email>z2doctor_chaoming@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Second affiliated Hospital, 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>Min Chao</last_name>
      <phone>+86 13957139239</phone>
      <email>z2doctor_chaoming@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03822130
org study id: IR2018001142
nct id: NCT03822130
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project intends to compare the clinical effects and side effects of three kinds of
      treatment methods in the treatment of unresectable gastric cancer by intra-arterial catheter
      infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy. It is clear
      that intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate is not
      suitable for the treatment of unresectable gastric cancer. The clinical practice value of
      resection of gastric cancer can provide high quality evidence-based medical basis for the
      treatment guidelines of advanced gastric cancer, and explore a new clinical technology with
      exact curative effect and higher safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful conversion rate of operation
time frame: 42 days
measure: ORR
time frame: 42 days
description: Objective Response rate
measure: PFS
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
description: progression-free survival
arm group label: Group 1
arm group type: Placebo Comparator
description: Systemic Chemotherapy + Oral Chemotherapy Group
arm group label: Group 2
arm group type: Experimental
description: Arterial catheter infusion chemotherapy plus oral chemotherapy group
arm group label: Group 3
arm group type: Experimental
description: Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group
intervention type: Drug
intervention name: Arterial catheter infusion chemotherapy
description: Arterial catheter infusion chemotherapy
arm group label: Group 2
arm group label: Group 3
intervention type: Drug
intervention name: Sodium Bicarbonate
description: Arterial catheter infusion Sodium Bicarbonate
arm group label: Group 3
intervention type: Drug
intervention name: Systemic Chemotherapy
description: Systemic Chemotherapy
arm group label: Group 1
intervention type: Drug
intervention name: Oral Chemotherapy
description: Oral Chemotherapy
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming Chao
phone: +86 13957139239
email: z2doctor_chaoming@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Stomach Neoplasms