Spots Global Cancer Trial Database for Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti- PD-1

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Trial Identification

Brief Title: Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti- PD-1

Official Title: Investigator-initiated Trial of Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti-PD-1 in Patients With PD-1 Resistant Digestive System Cancers

Study ID: NCT04130763

Conditions

Gastrointestinal System Cancer

Interventions

FMT capsule

Study Description

Brief Summary: To determine whether the fecal microbiota transplant (FMT) capsule can help reverse the resistance of anti-PD-(L)1 treatment in Gastrointestinal (GI) cancer patients.

Detailed Description: This study is designed to improve the response rate of anti-PD-(L)1 among patients with anti-PD-(L)1 resistant/refractory digestive (including gullet, stomach and intestine) system cancers through the intervention on their gut microbiota. Healthy people who have the gut microbiota profile similar to the responders of anti-PD-(L)1 therapy will be identified. The gut microbiota of these healthy people will be extracted to product FMT capsule. Gastrointestinal (GI) cancer patients who failed anti-PD-(L)1 treatment will be administrated with anti-PD-1 immunotherapy combined with FMT. The enrolled subjects will firstly receive 1-week of FMT therapy. Subsequently, each anti-PD-1 treatment will be combined with the maintenance dose of FMT capsules to ensure the efficiency of gut microbiota colonization. Each subject will receive anti-PD-1 therapy for 6 cycles. After the completion of both 3 and 6 cycles of therapy, safety and efficacy assessments will be conducted. The subjects who complete 3 cycles of treatment but are clinically evaluated as disease progression will not continue to the following 3 cycles of treatment.