FMT+SOX+Sintilimab As First-line Treatment for Advanced Gastric Cancer
ConditionGastric Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChangzhou No.2 People's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Currently participating in an interventional clinical study or receiving another investigational drug or investigational device within 4 weeks prior to initial dosing;
Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration;
Class III - IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;
Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment;
Trial design
Design model
Parallel
Treatments tested in this trial
Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy
Combination productParticipants received Fecal Microbiota Transplantation (FMT) combined with (Oxaliplatin + S-1)+Sintilimab
Treatment groups
198 Participants
are divided into 2 treatment groupsGroup A: Experimental ArmExperimental treatment 1 intervention
Group B: Placebo Comparator ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
2-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 monthsSecondary outcomes
1
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 months2
Objective Response Rate (ORR)
Objective response rate will be assessed by investigators.
Time frame
up to 24 months3
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 months4
The Diversity of Fecal Microbiota
This will be detected by 16s rRNA sequencing or metagenomes.
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov