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.
the investigatorse plan to initiate a prospective, multicenter randomized, double-blind, placebo-controlled phase II study, recruiting a total of 198 patients with previously untreated unresectable advanced or metastatic gastric/gastroesophageal junction adenocarcinoma in our hospital and 14 other hospitals. Randomly divided into Group A and Group B, Group A received FMT+SOX chemotherapy regimen +Sintilimab immunotherapy regimen, Group B only received SOX chemotherapy regimen+and Sintilimab immunotherapy regimen. If there is no progression of the disease after 4-6 cycles of first-line treatment, both groups of patients will enter the first-line maintenance treatment stage: S-1+Sintilimab, until disease progression, intolerance, or death occurs. The aim is to explore the efficacy and safety of FMT combined with SOX and Sintilimab in the treatment of advanced first-line gastric cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
198
Participants received Fecal Microbiota Transplantation (FMT) combined with (Oxaliplatin + S-1)+Sintilimab
Changzhou No.2 People's Hospital
Changzhou, China
RECRUITING2-year overall survival rate(2year-OS Rate)
The proportion of patients who have not died after 2 years of treatment
Time frame: up to 24 months
Median Progression-Free Survival (mPFS)
Observation for mPFS will be recorded until the end of follow-up after the start of 1st cycle of treatment.
Time frame: up to 24 months
Objective Response Rate (ORR)
Objective response rate will be assessed by investigators.
Time frame: up to 24 months
Incidence of Adverse events (AEs)
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Time frame: up to 24 months
The Diversity of Fecal Microbiota
This will be detected by 16s rRNA sequencing or metagenomes.
Time frame: up to 24 months
Quality of Life (QoL)
QoL will be evaluated by EORTC-QLQ-C30.
Time frame: up to 24 months
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