Actively Recruiting
A Prospective, Randomised Placebo Controlled Trial of Fecal Microbiota Transplantation Combined with Chemotherapy and Anti-PD1/PD-L1 Therapy in Patients With Advanced Gastric Cancer
Led by Changhai Hospital · Updated on 2025-06-10
124
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of fecal microbiota transplantation (FMT) capsules combined with chemotherapy and anti-PD1/PDL1 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-PD1/PD-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.
CONDITIONS
Brief Title
Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and provide written informed consent
- Age 18 years or older, male or female
- Pathologically confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma or esophagogastric junction adenocarcinoma
- Able and willing to provide tumor tissue samples
- At least one measurable extracranial target lesion according to iRECIST
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 3 months
You will not qualify if you...
- Conditions absolutely contraindicating FMT such as toxic megacolon, inflammatory bowel disease, anatomic contraindications to colonoscopy, or prior colectomy
- Currently participating in another clinical trial or received investigational therapy/device within 4 weeks
- Receiving any systemic antibiotics at the time of study entry
- Diagnosis of immunodeficiency or receiving systemic steroid therapy above 10 mg prednisone daily or equivalent within two weeks prior to treatment
- Severe anaphylactic food allergies or severe hypersensitivity to propofol
- Serious coexisting illnesses
- HIV infection or AIDS-related illness
- Active infection with hepatitis A, B, or C viruses
- Received a live vaccine within 4 weeks prior to first treatment dose
- Known psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant or breastfeeding females
- Active central nervous system metastases or leptomeningeal involvement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive Fecal Microbiota Transplantation or placebo capsules combined with chemotherapy and anti-PD1/PD-L1 therapy.
Oral capsules administered three days initially and then every three weeks; intravenous chemotherapy and anti-PD1/PD-L1 therapy every three weeks
Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
X
Xiangyu Kong, associate professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here