Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer

Overview

This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with Advanced Gastric Cancer

Full Title of Study: “Maintenance Treatment With Capecitabine Plus Apatinib vs. Apatinib and Observation After First-line XELOX/SOX Chemotherapy for Patients With Advanced Gastric Cancer: a Multicenter, Randomized, Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 16, 2020

Interventions

  • Drug: Apatinib+Capecitabine
    • Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d
  • Drug: Apatinib
    • Apatinib 250mg po Qd

Arms, Groups and Cohorts

  • Experimental: Maintenance Treatment Group A
    • Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
  • No Intervention: Observation Group
    • Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
  • Experimental: Maintenance Treatment Group B
    • Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer

Clinical Trial Outcome Measures

Primary Measures

  • PFS
    • Time Frame: 36 months
    • From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary Measures

  • OS
    • Time Frame: 36 months
    • From date of randomization until the date of first documented death from any cause, assessed up to 36 months

Participating in This Clinical Trial

Inclusion Criteria

1. aged 18-75;

2. had histologically confirmed unresectable and/or metastatic (primary or recurrent) adenocarcinoma of the stomach or gastroesophageal junction;

3. received 4-6 cycles of Xelox/SOX regimens as first-line chemotherapy and the response was not progression disease (PD);

4. ECOG 0-2;

5. Patients were tested for tumor HER2 status before treatment, and patients with HER2-negative disease;

6. presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines;

7. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;

8. Adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN

9. Receiving no form of chemotherapy, targeted therapy or other study medication;

Exclusion Criteria

1. previous radiotherapy to the abdomen;

2. previous treatment for advanced disease (neoadjuvant chemotherapy was permitted if administered >6 months before enrollment);

3. pregnant or lactating women or women of childbearing potential;

4. disease progression during the first-line chemotherapy;

5. active gastrointestinal bleeding, arterial thrombosis or cerebrovascular accident within 6 months before enrollment

6. previous treatment of apatinib and Ramucirumab

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Huazhong University of Science and Technology
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xianglin Yuan, Professor, Chief physician – Huazhong University of Science and Technology
  • Overall Official(s)
    • Xianglin Yuan, PhD,MD, Study Chair, Tongji Hospital
  • Overall Contact(s)
    • Xianglin Yuan, PhD,MD, 8627-83663406, xlyuan1020@163.com

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