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 treatment in patients with advanced pancreatic ductal adenocarcinoma that cannot be removed by surgery or has spread. This phase 1 open-label trial aims to confirm the safety of this combined therapy while also studying clinical outcomes, gut microbiome changes, immune system responses, and patient experiences. The study is conducted at the Verspeeten Family Cancer Centre within the London Health Sciences Centre. Participants receive FMT using 100 grams of healthy donor stool delivered in 36-40 oral capsules. Before the FMT, they take polyethylene glycol (PEG3350) dissolved in water the evening prior to help prepare the gut. Chemotherapy is administered with gemcitabine at 1000 mg/m2 and nab-paclitaxel at 125 mg/m2 intravenously on days 1, 8, and 15 of each 28-day cycle. Patients continue this combination as first-line treatment, with some allowed to receive palliative radiation if needed. The trial includes 20 patients and focuses on the safety of combining these treatments. Throughout the study, participants provide informed consent and are monitored for adverse events up to about four years after starting treatment. Researchers assess disease status using imaging criteria, track immune and microbiome changes, and record patient outcomes. They also observe any side effects from the combined therapy. The total study duration includes treatment cycles and long-term safety follow-up to better understand the risks and effects of this novel combination approach.

CHemotherapy and Stool Transplant in PDAC (CHASe-PDAC)