Gastric Cancer
Conditions
Keywords
advanced gastric cancer, apatinib, capecitabine, maintenance
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
Interventions
DRUGApatinib+Capecitabine
Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d
DRUGApatinib
Apatinib 250mg po Qd
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| OS | 36 months | From date of randomization until the date of first documented death from any cause, assessed up to 36 months |
Countries
China
Contacts
Primary ContactXianglin Yuan, PhD,MD
Backup ContactPing Peng, PhD,MD
Outcome results
None listed