A Prospective, Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Patients With Advanced Gastric Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules combined with chemotherapy and anti-PD1/PDL1 therapy in the advanced gastric cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Voluntarily participate in this study and provide written informed consent. Age ≥ 18 years , male or female. Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma.
• Able and willing to provide tumor tissue. At least one measurable extracranial target lesion according to iRECIST. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Life expectancy ≥3 months.
Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xiangyu Kong, associate professor
xiangyukong185@hotmail.com
13564644397
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 124
Treatments
Placebo_comparator: Placebo capsules
Placebo capsules will be administered orally three days and then every three weeks for 24 weeks. SOX and anti-PD1/PD-L1 will be intravenously infused every three weeks for 24 weeks.
Experimental: FMT capsules
FMT capsules will be administered orally three days and then every three weeks for 24 weeks. SOX and anti-PD1/PD-L1 will be intravenously infused every three weeks for 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital