NCT06405113

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

Fecal Microbiota Transplantation Combined with SOX and Sintilimab As First-line Treatment for Advanced Gastric Cancer:A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study (FMT-JSNO-01)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Changzhou No.2 People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

the investigatorse plan to initiate a prospective, multicenter randomized, double-blind, placebo-controlled phase II study, recruiting a total of 198 patients with previously untreated unresectable advanced or metastatic gastric/gastroesophageal junction adenocarcinoma in our hospital and 14 other hospitals. Randomly divided into Group A and Group B, Group A received FMT+SOX chemotherapy regimen +Sintilimab immunotherapy regimen, Group B only received SOX chemotherapy regimen+and Sintilimab immunotherapy regimen. If there is no progression of the disease after 4-6 cycles of first-line treatment, both groups of patients will enter the first-line maintenance treatment stage: S-1+Sintilimab, until disease progression, intolerance, or death occurs. The aim is to explore the efficacy and safety of FMT combined with SOX and Sintilimab in the treatment of advanced first-line gastric cancer patients.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy	Participants received Fecal Microbiota Transplantation (FMT) combined with (Oxaliplatin + S-1)+Sintilimab

Timeline

• Start date: 2024-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-05-08
• Last updated: 2025-02-20

Locations

1 site across 1 country: China