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

Phase 3

• Conditions: Gastric Cancer
• Interventions: Drug: Apatinib+Capecitabine; Drug: Apatinib

• Registration Number: NCT03598348
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-24
• Study Start: 2018-01-16
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-15
• Last Update Submitted: 2018-07-15
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26
• Primary Completion: 2020-01-16
• Study Completion: 2020-10-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maintenance Treatment Group A	Apatinib+Capecitabine	Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
Maintenance Treatment Group B	Apatinib	Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer

Primary Outcome Measures

Name	Time	Method
PFS	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 Outcome Measures

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

Trial Locations

Locations (1)

Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China