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NCT06405113Not yet recruiting

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)
Changzhou No.2 People's HospitalPhase 2ClinicalTrials.govcombination product
Verified
Study focus
Disease/Condition
Gastric Cancer
Drug/Device/Intervention
Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
Changzhou No.2 People's Hospital
Timeline & enrollment
Phase
Phase 2
Start date
Jun 01, 2024
End date
Jun 01, 2027
Enrollment
198 participants
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
Gastric ulcerMalignant neoplasm of stomachMalignant neoplasm: Body of stomachCarcinoma in situ: StomachMalignant neoplasm: Stomach, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06405113
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.