OncoMatch/Clinical Trials/NCT06405113
FMT+SOX+Sintilimab As First-line Treatment for Advanced Gastric Cancer
Is NCT06405113 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06405113 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
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 qualifyRelated pages