Clinical trial · Interventional
A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer
A Double-Blind, Randomized, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-Line Therapy in Patients With Advanced Gastric Cancer.
- 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 2 arm study will compare the efficacy and safety of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in participants who have not received prior chemotherapy for advanced or metastatic gastric cancer. Participants will be randomized to one of two treatment groups Bevacizumab + Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bevacizumab, Capecitabine and Cisplatin
- description
- Participants will receive bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m\^2) orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
- interventionNames
- Drug: Bevacizumab
- Drug: Capecitabine
- Drug: Cisplatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo, Capecitabine and Cisplatin
- description
- Participants will receive placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable, locally advanced or metastatic disease, not amenable to curative therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 * Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) Exclusion Criteria: * Previous chemotherapy for locally advanced or metastatic gastric cancer * Previous platinum or anti-angiogenic therapy * Radiotherapy within 28 days of randomization * Evidence of Central Nervous System (CNS) metastasis at baseline
References
Publications (0)
Data not yet available