OncoMatch/Clinical Trials/NCT06405113
FMT+SOX+Sintilimab As First-line Treatment for Advanced Gastric Cancer
Is NCT06405113 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy for gastric cancer.
Treatment: Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative (negative)
Disease stage
Metastatic disease required
Non resectable Her-2 negative advanced or metastatic gastric/gastroesophageal junction adenocarcinoma confirmed by histopathology and/or cytology
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor treatment
Have not received anti-tumor treatment in the past
Cannot have received: proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.)
Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration
Cannot have received: major surgical treatment
received major surgical treatment within 3 weeks before the first administration
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; platelet ≥75×10^9/L; hemoglobin ≥90 g/L (no blood transfusion or erythropoietin dependence within 14 days)
Kidney function
serum creatinine ≤1.5x ULN or creatinine clearance ≥50 mL/min; urine protein <2+; if urine protein ≥2+, 24-hour urine protein quantification <1g
Liver function
serum total bilirubin (TBIL) ≤2x ULN; ALT and/or AST ≤5x ULN; serum albumin ≥28 g/L; ALP ≤5x ULN
adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify