Actively Recruiting
FMT+SOX+Sintilimab As First-line Treatment for Advanced Gastric Cancer
Led by Changzhou No.2 People's Hospital · Updated on 2025-02-20
198
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
FMT+SOX+Sintilimab As First-line Treatment for Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old, inclusive
- Able to understand the study and voluntarily sign informed consent
- Have unresectable Her-2 negative advanced or metastatic gastric/gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology
- Have at least one measurable tumor lesion according to RECIST 1.1
- Have not received any prior anti-tumor treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 3 months
- Adequate organ and bone marrow function based on laboratory tests within 7 days prior to enrollment
- Negative pregnancy test for females of reproductive age within 3 days before initial treatment
- Use medically approved contraception during treatment and for 6 months after study treatment ends
You will not qualify if you...
- Currently participating in another interventional clinical study or using investigational drugs/devices within 4 weeks before starting this study
- Received anti-tumor proprietary Chinese medicines or immunomodulatory drugs within 2 weeks, or major surgery within 3 weeks before first dose
- Have severe heart failure (Class III-IV) or uncontrolled significant arrhythmias
- Experienced arterial thrombosis, embolism, or ischemia (like heart attack or stroke) within 6 months before treatment
- Known allergy to any study drug
- Require long-term systemic corticosteroids; intermittent inhaled corticosteroids or bronchodilators allowed
- Have symptomatic central nervous system metastases; stable asymptomatic brain metastases with specific conditions allowed
- Use hormone therapy within 3 days before first dose
- Have active infection requiring treatment or recent use of systemic anti-infective drugs within 1 week before first dose
- Have unresolved toxicity or complications from prior interventions (grade 2 or higher)
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Pregnant or breastfeeding
- Medical history or conditions that may interfere with study participation or safety as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Changzhou No.2 People's Hospital
Changzhou, China
Actively Recruiting
Research Team
H
hua jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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