Clinical Trial

FMT+SOX+Sintilimab As First-line Treatment for Advanced Gastric Cancer

Recruiting Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-05-07.
Status change: Not Yet Recruiting → Recruiting 2025-02-17
Trial Details
NCT Number NCT06405113
Lead Sponsor Changzhou No.2 People's Hospital
Conditions Gastric Cancer
Enrollment 198 participants
Start Date 2024-06-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-20