Clinical trial · Interventional
Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer
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
NCT03598348CI-TRIAL-00033962unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Apatinib+Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Maintenance Treatment Group A
- description
- Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
- interventionNames
- Drug: Apatinib+Capecitabine
- type
- NO_INTERVENTION
- label
- Observation Group
- description
- Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
- type
- EXPERIMENTAL
- label
- Maintenance Treatment Group B
- description
- Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.