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

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Apatinib+Capecitabine; Drug: Apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03598348

TJCC006

Details and patient eligibility

About

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

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 3 patient groups

Maintenance Treatment Group A

Experimental group

Description:

Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer

Treatment:

Drug: Apatinib+Capecitabine

Observation Group

No Intervention group

Description:

Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer

Maintenance Treatment Group B

Experimental group

Description:

Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer

Treatment:

Drug: Apatinib