FMT+SOX+Sintilimab As First-line Treatment for Advanced Gastric Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Subjects aged 18-80 (including 18 and 80 years old); * Understand the research steps and content, and voluntarily sign a written informed consent form; * Non resectable Her-2 negative advanced or metastatic gastric/gastroesophageal junction adenocarcinoma confirmed by histopathology and/or cytology, excluding all other histological types; * At least one measurable lesion, according to RECIST 1.1 standard; * Have not received anti-tumor treatment in the past; * The physical status score of Eastern Tumor Collaboration Group (ECOG) was 0-1; * Expected survival time ≥ 3 months; * Have adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements (no blood components, cell growth factors, albumin or other corrective drugs are allowed within 14 days prior to obtaining laboratory examination), as follows: 1) Blood routine: absolute neutrophil count (ANC) ≥1.5×109/L, platelet (PLT) ≥75×109/L, hemoglobin