CHemotherapy and Stool Transplant in PDAC (CHASe-PDAC)
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.
| Condition(s) | Unresectable or Metastatic Advanced Pancreatic Ductal Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * Patients must be 18-years old or older * Patients must have a confirmed diagnosis of unresectable or metastatic pancreatic ductal adenocarcinoma. Diagnosis confirmation may include pathologic assessment or radiographic/biomarker determination of PDAC when obtaining a tumour sample is not feasible/successful. The latter case requires review at the Pancreas Multi-disciplinary Case Conference (MCC) * Patients with ECOG performance of 0-2 * Patients who have consented to treatment with first-line gemcitabine with nab-paclitaxel at the discretion of their primary oncologist. Patients must receive at least one dose of both chemotherapy agents to be considered eligible for evaluation. * Patients must be able to provide written informed consent and understand the infectious r |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | John Lenehan |
| Locations | London, Ontario, Canada |
| Start date | 2025-01-08 |
| NCT ID | NCT06393400 |
| Official listing | https://clinicaltrials.gov/study/NCT06393400 |