Phase 1 Study of Oral Fecal Microbiota Transplantation Combined with Gemcitabine and Nab-paclitaxel Chemotherapy for Advanced Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the safety of combining oral fecal microbiota transplantation FMT with standard chemotherapy drugs gemcitabine and nab-paclitaxel as a first-line treatment for patients with unresectable or metastatic pancreatic ductal adenocarcinoma PDAC. This phase 1 open-label trial involves 20 patients and aims to confirm the safety of this combined therapy, analyze gut microbiome changes, profile immune responses, and explore patient-related outcomes. The study is conducted at the Verspeeten Family Cancer Centre. Participants receive a single oral dose of FMT consisting of 100 grams of healthy donor stool in 36-40 capsules following preparation with a polyethylene glycol laxative. Then, at least seven days later, they begin chemotherapy with gemcitabine and nab-paclitaxel administered intravenously on Days 1, 8, and 15 of each 28-day cycle. This combination therapy continues as first-line treatment for advanced PDAC. During the study, participants undergo assessments of safety by monitoring adverse events through approximately four years until study completion. Researchers evaluate progression-free survival, overall survival up to 24 months, tolerability of FMT capsules, objective response rate, and clinical benefit rate. Patients are monitored for clinical outcomes, immune and microbiome changes, and patient experiences throughout the study period starting from enrollment.

CHemotherapy and Stool Transplant in PDAC (CHASe-PDAC)