drugset / Trial / NCT06405113
FMT+SOX+Sintilimab As First-line Treatment for Advanced Gastric Cancer
RandomizedParallel-groupTriple-blindTreatment
Summary
the investigators plan to initiate a prospective, multicenter, randomized, double-blind, placebo-controlled phase II study, recruiting 198 patients with advanced gastric/gastroesophageal junction adenocarcinoma who have not received prior treatment. Randomly divided into two groups, one group is the group of fecal microbiota transplantation(FMT)+SOX+Sintilimab, and the other group is the group of SOX+Sintilimab. Compare the 2-year OS rates of the two groups to verify whether the addition of FMT to first-line treatment can improve the prognosis of gastric cancer patients.
Timeline
- Start
- 2024-06-01
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Oxaliplatin | Small molecule | — | — |
| Background | S-1 | Small molecule | — | — |
| Background | Sintilimab | Monoclonal antibody | — | — |