FMT Capsule in Combination with Anti-PD-1 Therapy

FMT capsules administration starts in the first week of enrollment. Capsules are taken for three consecutive days in the first week. From week 2, anti-PD-1 therapy will be administrated in combination with the maintenance dose of FMT treatment once every two weeks for up to 6 times.

FMT capsule

Lin Shen, MD

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.

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.

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

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

Number of subjects with objective responses (Complete Response (CR) + Partial Response (PR)) divided by total number of subjects, per iRECIST.

Rate of abnormal vital signs and laboratory test results that are determined to be clinically significant prior to the first anti-PD-1 immunotherapy treatment.

The number of grade 2 or above adverse events that is related to FMT prior to the first anti-PD-1 immunotherapy treatment.

Compare the changes in CD8+PD-1+T cells, Ki67+CD8+ T cells before and after treatment between response subjects and non-response subjects (evaluated by iRECIST).

Compare the changes in T-cell receptor diversity (quantified by immune repertoire sequencing analyses), CD8+CCR7+CD45RA+T cells, CD4+CCR7+CD45RA+ T cells and CD4 + Foxp3 + T cells before and after treatment between response subjects and non-response subjects (evaluated by iRECIST).

Compare the changes in cells expressing IFN-γ before and after treatment between response subjects and non-response subjects (per iRECIST).

Compare the changes in bacterial abundance and bacterial diversity before and after treatment between response subjects and non-response subjects (per iRECIST).

Rate of abnormal vital signs, physical examination results, 12-lead electrocardiogram and laboratory test results that are determined to be clinically significant from the beginning of the first anti-PD-1 immunotherapy treatment to the end of study.

The number of grade 2 or above adverse events that is related to FMT from the beginning of the first anti-PD-1 immunotherapy treatment to the end of study.

Spots Global Cancer Trial Database for fmt capsule

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Spots Global Cancer Trial Database for fmt capsule

Every month we try and update this database with for fmt capsule cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fmt capsule cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.