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

NCT06405113 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-02-20

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy

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

Sponsors & Collaborators

  • Changzhou No.2 People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2027-06-01
Completion
2027-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06405113 on ClinicalTrials.gov