Actively Recruiting
Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer
Led by Changhai Hospital · Updated on 2025-06-10
124
Participants Needed
1
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- 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...
- Absolute contraindications to FMT such as toxic megacolon, inflammatory bowel disease, anatomic contraindications to colonoscopy, or prior colectomy
- Currently participating in another study or have received investigational agents or devices within 4 weeks
- Currently using any systemic antibiotics
- Diagnosis of immunodeficiency or receiving systemic steroid therapy above 10 mg prednisone daily or equivalent within 2 weeks prior to trial
- Severe anaphylactic reaction to any food or severe hypersensitivity reaction to propofol
- Serious concomitant illnesses as determined by the investigator
- HIV infection or AIDS-related illness
- Active infection with HAV, HBV, or HCV
- Received a live vaccine within 4 weeks prior to treatment; inactivated vaccines like seasonal influenza or COVID-19 vaccines are allowed
- 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
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Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
X
Xiangyu Kong, associate professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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