FMT+SOX+Sintilimab as First-line Treatment for Advanced Gastric Cancer - Trial NCT06405113
Access comprehensive clinical trial information for NCT06405113 through Pure Global AI's free database. This Phase 2 trial is sponsored by Changzhou No.2 People's Hospital and is currently Not yet recruiting. The study focuses on Gastric Cancer. Target enrollment is 198 participants.
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Study Focus
Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy
Interventional
combination product
Sponsor & Location
Changzhou No.2 People's Hospital
Timeline & Enrollment
Phase 2
Jun 01, 2024
Jun 01, 2027
Primary Outcome
2-year overall survival rate(2year-OS Rate)
Summary
We 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06405113
Non-Device Trial