An Open-label, Single-arm, Phase 1 Study of the Combination of FMT and Gemcitabine with Nab-paclitaxel As First-line Therapy in Patients with Advanced Pancreatic Ductal Adenocarcinoma. (CHASe-PDAC)

NCT06393400 Phase 1 RECRUITING

To confirm the safety of combining oral fecal microbiota transplantation (FMT) with gemcitabine and nab-paclitaxel chemotherapy as first line treatment in patients with unresectable or metastatic pancreatic ductal adenocarcinoma.

Details

Lead sponsor	John Lenehan
Phase	Phase 1
Status	RECRUITING
Enrolment	20
Start date	2025-01-08
Completion	2028-02

Conditions

• Unresectable or Metastatic Advanced Pancreatic Ductal Adenocarcinoma

Interventions

• Fecal Microbiota Transplantation
• PEG3350
• Gemcitabine
• nab-Paclitaxel

Primary outcomes

• Adverse Events — Approximately end of year 4 (Study Completion)
  FMT in combination with systemic therapy in patients with advanced PDAC has not been studied to our knowledge. Prior to proceeding with a larger study, this phase I study will include 20 patients receiving G-nP who will receive a single FMT with healthy donor stool prior to the first dose of chemotherapy. There are well-known toxicities associated with these 2 chemotherapeutic agents, several of which affect the gastrointestinal tract. The most common side effects resulting from FMT are primarily mild gastrointestinal effects. FMT has been found to be safe when combined with ICIs and there has been no increase in the number of toxicities or severity observed. The measure of safety in this trial will be assessing for treatment-related adverse events that will be graded according to the NCI-CTCAE v5. A positive trial result with respect to toxicity will be designated if there are no unexpected or more severe toxicities associated than with the chemotherapy drugs alone.

Countries

Canada