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RECRUITING
NCT06405113
PHASE2

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

Sponsor: Changzhou No.2 People's Hospital

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

198

Start Date

2024-06-01

Completion Date

2027-06-01

Last Updated

2025-02-20

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy

Participants received Fecal Microbiota Transplantation (FMT) combined with (Oxaliplatin + S-1)+Sintilimab

Locations (1)

Changzhou No.2 People's Hospital

Changzhou, China