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Brief Title: CHemotherapy And Stool Transplant in PDAC (CHASe-PDAC)
Official Title: 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.
Study ID: NCT06393400
Brief 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.
Detailed Description: This is a phase 1 open-labelled, non-randomized safety trial examining oral fecal microbiota transplantation (FMT) with healthy donor stool in combination with standard of care (SOC) gemcitabine and nab-paclitaxel (GnP) in patients with advanced (unresectable and metastatic) pancreatic ductal adenocarcinoma (PDAC) as first-line therapy. A total of 20 eligible patients will be treated with study treatment. The purpose of the trial is to confirm the safety of combined therapy, assess clinical outcomes, perform gut microbiome analysis, systemic immune profiling, and explore patient-related outcomes. This trial will be conducted at the Verspeeten Family Cancer Centre (formerly known as the London Regional Cancer Program) at London Health Sciences Centre.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Verspeeten Family Cancer Centre (formerly known as the London Regional Cancer Program) London Health Sciences Centre, London, Ontario, Canada