Actively Recruiting
CHemotherapy and Stool Transplant in PDAC (CHASe-PDAC)
Led by John Lenehan · Updated on 2025-01-23
20
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CHemotherapy and Stool Transplant in PDAC (CHASe-PDAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years old or older
- Confirmed diagnosis of unresectable or metastatic pancreatic ductal adenocarcinoma
- ECOG performance status of 0 to 2
- Consent to first-line treatment with gemcitabine and nab-paclitaxel and have received at least one dose of both
- Able to provide written informed consent and understand risks associated with FMT
- Ability to swallow capsules
- Understand there are unknown long-term safety risks with FMT
- Have measurable disease as defined by RECIST version 1.1
You will not qualify if you...
- Prior cytotoxic chemotherapy for pancreatic ductal adenocarcinoma
- Pregnant, breastfeeding, or planning to conceive/father children during the study
- Immunodeficiency diagnosis (e.g., HIV, organ transplant)
- Use of antibiotics within 7 days before FMT
- Use of probiotics within 72 hours before FMT and during first 3 months of chemotherapy
- Chronic intestinal diseases such as celiac disease, malabsorption, or primary colonic tumor
- Absolute contraindications to FMT including toxic megacolon, severe dietary allergies, or inflammatory bowel disease
- Serious illnesses like uncontrolled heart failure, bleeding disorders, autoimmune diseases, severe lung diseases, or active infections
- Active infection requiring systemic treatment
- Receipt of live vaccine within 4 weeks before treatment
- Psychiatric or substance abuse disorders interfering with study cooperation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Verspeeten Family Cancer Centre (formerly known as the London Regional Cancer Program) London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
Research Team
J
John G Lenehan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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