Actively Recruiting
The Efficacy of PD-1 Monoclonal Antibody Combined With Chemotherapy in Metastatic Gastric Cancer Based on Gut Microbiota
Led by Fudan University · Updated on 2026-02-10
300
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed as a single-center, open-label, phase II exploratory trial. Patients with advanced or locally advanced gastric cancer who have not received chemotherapy or immunotherapy before are eligible for inclusion. They will receive a first-line two-drug combination chemotherapy regimen (FOLFOX, XELOX, or SOX, determined by the attending physician) in combination with a PD-1 monoclonal antibody (nivolumab, sintilimab, tislelizumab, or pembrolizumab, determined by the attending physician). Fruquintinib can be added on this basis (only for patients enrolled in the HMPL-013-SH-GC103 study). The aim is to evaluate whether the gut microbiota has a predictive role in the efficacy of immunotherapy combined with chemotherapy for metastatic gastric cancer. A total of 100 patients will be enrolled in the study. Gut microbiota will be measured at the following three time points: 1. Within 3 days before the first chemotherapy (designated as time 0) 2. Within 3 days before the third chemotherapy (designated as time 1) 3. After the sixth chemotherapy cycle, or within 1 week after disease progression if it occurs within the sixth cycle (designated as time 2)
CONDITIONS
Official Title
The Efficacy of PD-1 Monoclonal Antibody Combined With Chemotherapy in Metastatic Gastric Cancer Based on Gut Microbiota
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 with expected survival over 3 months
- Metastatic or locally advanced gastric cancer confirmed by cytology or histopathology
- Laboratory tests within 7 days before screening showing: neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 80×10⁹/L, hemoglobin ≥ 80 g/L, total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT and AST ≤ 2.5× ULN (or ≤ 5× ULN if liver metastasis present), albumin ≥ 30 g/L, serum creatinine ≤ 1.5× ULN or creatinine clearance rate ≥ 60 ml/min
- At least one measurable lesion according to RECIST 1.1 criteria
- No previous palliative chemotherapy and planned for first-line immunotherapy combined with chemotherapy as determined by the attending physician
- Signed informed consent form with understanding of the study purpose and procedures
You will not qualify if you...
- Pregnant or breastfeeding women, or women of childbearing age without adequate contraception
- History of other malignant tumors within the past 5 years, except cured cervical carcinoma in situ or non-melanoma skin cancer
- Uncontrolled primary brain tumors or central nervous system metastases, or significant intracranial pressure or neuropsychiatric symptoms
- Severe or uncontrolled heart disease or unstable cardiovascular conditions within 6 months prior to enrollment
- Definite neurological or psychiatric disorders including dementia or seizures
- Severe or uncontrolled infections, active disseminated intravascular coagulation, or bleeding tendencies
- Significant damage to vital organs
- Pleural effusion or ascites causing respiratory symptoms requiring treatment
- Any other conditions deemed unsuitable by the investigator
- Long-term use of probiotics or antibiotics prior to the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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