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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Apatinib+Capecitabine
* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18-75； had histologically confirmed unresectable and/or metastatic (primary or recurrent) adenocarcinoma of the stomach or gastroesophageal junction； received 4-6 cycles of Xelox/SOX regimens as first-line chemotherapy and the response was not progression disease (PD); ECOG 0-2； Patients were tested for tumor HER2 status before treatment, and patients with HER2-negative disease； presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines； Subjects has to voluntarily join the study and sign the Informed Consent Form for the study; 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 Receiving no form of chemotherapy, targeted therapy or other study medication; Exclusion Criteria: previous radiotherapy to the abdomen； previous treatment for advanced disease (neoadjuvant chemotherapy was permitted if administered >6 months before enrollment)； pregnant or lactating women or women of childbearing potential； disease progression during the first-line chemotherapy; active gastrointestinal bleeding, arterial thrombosis or cerebrovascular accident within 6 months before enrollment previous treatment of apatinib and Ramucirumab

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maintenance Treatment Group A<br>Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer | Drug: Apatinib+Capecitabine<br>* Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d<br>* Other names: capecitabine;|
| No Intervention: Observation Group<br>Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer | |
| Experimental: Maintenance Treatment Group B<br>Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer | Drug: Apatinib<br>* Apatinib 250mg po Qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | 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 | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | From date of randomization until the date of first documented death from any cause, assessed up to 36 months | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced gastric cancer, apatinib, capecitabine, maintenance