Study of Fecal Microbiota Transplant Capsules with Chemotherapy and Anti-PD1PD-L1 in Advanced Gastric Cancer Patients

What this Trial Is About

Researchers are evaluating the effectiveness and safety of fecal microbiota transplantation FMT capsules combined with chemotherapy and anti-PD1PDL1 therapy in adults with advanced gastric cancer. This randomized, double-blind, placebo-controlled study aims to understand whether adding FMT capsules to standard treatments can improve outcomes for patients with locally advanced, unresectable, or metastatic gastric or esophagogastric junction adenocarcinoma. Participants will be assigned to receive either FMT capsules or placebo capsules orally for three days initially and then every three weeks for 24 weeks. Alongside these capsules, all participants will receive SOX chemotherapy and anti-PD1PD-L1 therapy intravenously every three weeks for the same 24-week period. The study compares these two groups to assess the impact of FMT combined with standard cancer treatments. During the study, participants will undergo evaluations including tumor tissue collection, imaging to measure tumor response, and quality of life questionnaires. Researchers will monitor the objective response rate, disease control rate, progression-free survival, overall survival, changes in gut microbiome and immunity, and treatment-related adverse events. Follow-up assessments will continue up to two years after treatment to observe long-term effects and overall health outcomes.

Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer