Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-01-08
2028-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Anti-PD-1/PD-L1 Antibodies Plus Gemcitabine and Cisplatin for Advanced CCA
NCT07291063
A Study of SLC-0111 and Gemcitabine for Metastatic Pancreatic Ductal Cancer in Subjects Positive for CAIX
NCT03450018
Nab-Paclitaxel + Cisplatin + Gemcitabine in Untreated Metastatic Pancreatic Adenocarcinoma
NCT03915444
Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
NCT04324307
Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients
NCT05947825
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fecal Microbiota Transplantation
A single Fecal Microbiota Transplantation (FMT) with 100 g of healthy stool in 36-40 oral capsules once 24 hours after Polyethylene Glycol laxative preparation, followed by gemcitabine 1000 mg/m2 intravenously (IV) and nab-paclitaxel 125 mg/m2 IV on Day 1, Day 8, and Day 15 of each 28-day cycle at least 7 days after FMT.
PEG3350
Polyethylene Glycol 3350 17 g oral dissolved in 4 litres of water consumed the evening before FMT.
Other Names:
* PEG3350
* RestoraLAX
* MiraLAX
Gemcitabine
Gemcitabine 1000 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle.
Other Names:
\- Gemzar
nab-Paclitaxel
nab-Paclitaxel 125 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle.
Other Names:
\- Abraxane
Fecal Microbiota Transplantation
Fecal Microbiota Transplantation with 100 g of healthy donor stool in 36-40 oral capsules once
Other Names:
* FMT
* Stool Transplant
* Poop Transplant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PEG3350
Polyethylene Glycol 3350 17 g oral dissolved in 4 litres of water consumed the evening before FMT.
Other Names:
* PEG3350
* RestoraLAX
* MiraLAX
Gemcitabine
Gemcitabine 1000 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle.
Other Names:
\- Gemzar
nab-Paclitaxel
nab-Paclitaxel 125 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle.
Other Names:
\- Abraxane
Fecal Microbiota Transplantation
Fecal Microbiota Transplantation with 100 g of healthy donor stool in 36-40 oral capsules once
Other Names:
* FMT
* Stool Transplant
* Poop Transplant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 risks associated with FMT administration
* Patients must understand that there are non-infectious risks associated with FMT administration
* Ability to ingest capsules
* Understand that data regarding the long-term safety risk of FMT are lacking
* Have evaluable disease as per RECIST version 1.1
Patients may receive other localized therapies with palliative intent while on therapy to include external beam radiation to areas of metastatic disease. Stratification of outcomes will include identifying patients that receive palliative radiation to the primary tumour itself.
Exclusion Criteria
* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit
* Has a diagnosis of immunodeficiency (e.g. HIV, organ transplantation)
* Ongoing use of antibiotics or previous use of antibiotics within 7 days prior to the FMT procedure
* Probiotic supplements and food products labeled as containing probiotics must be discontinued a minimum of 72 hours before FMT administration and are not permitted during the first 3 months of chemotherapy treatment
* Presence of a chronic intestinal disease (e.g. Celiac, malabsorption, primary colonic tumor)
* Presence of absolute contra-indications to FMT administration
* Toxic megacolon
* Severe dietary allergies (e.g. shellfish, nuts, seafood)
* Inflammatory bowel disease
* Has serious concomitant illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, uncontrolled hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders
* This includes HIV or AIDS-related illness, or active HBV and HCV
* Has an active infection requiring systemic therapy
* Patient has received a live vaccine within 4 weeks prior to the first dose of treatment
* Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Special considerations include patients who are unable to tolerate the combination of gemcitabine with nab-paclitaxel, and subsequently after starting chemotherapy are transitioned to gemcitabine alone at the discretion of their treating oncologist. Such patients will not be removed or disqualified from continuing in the study but their clinical outcomes will be stratified between those who received nab-paclitaxel with gemcitabine and those who transitioned to gemcitabine alone. In general, this scenario is not expected to commonly occur in this trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
John Lenehan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
John Lenehan
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Verspeeten Family Cancer Centre (formerly known as the London Regional Cancer Program) London Health Sciences Centre
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
John G Lenehan, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ReDA 14577
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.