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
Qualifiers
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
Treatments tested in this trial
- Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy
Treatment groups
198 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov