RecruitingNot ApplicableNCT06346093

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

A Prospective, Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Patients With Advanced Gastric Cancer


Sponsor

Changhai Hospital

Enrollment

124 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules combined with chemotherapy and anti-PD1/PDL1 therapy in the advanced gastric cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests fecal microbiota transplantation (FMT) — transferring healthy gut bacteria from a donor into a patient — as a potential way to improve outcomes in people with advanced stomach cancer. Researchers believe that the gut microbiome may influence how well immunotherapy works. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced, unresectable, or metastatic stomach or gastroesophageal junction cancer, confirmed by biopsy - At least one tumor can be measured on scans - Your performance status is good (ECOG 0 or 1) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have a condition that makes colonoscopy unsafe (such as toxic megacolon or inflammatory bowel disease) - You have had a colectomy - You are already in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFecal Microbiota Transplantation Capsules

FMT Capsules in Combination with Chemotherapy and Anti-PD1/PD-L1 Therapy

PROCEDUREPlacebo

Mainly composed of starch, the appearance, shape, color, and size are exactly the same as FMT capsules


Locations(1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

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NCT06346093


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