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New treatment option for Unresectable or Metastatic Advanced Pancreatic Ductal Adenocarcinoma
Official title CHemotherapy and Stool Transplant in PDAC (CHASe-PDAC)
ClinicalTrials.gov ID: NCT06393400
What this study is testing
What is Fecal Microbiota Transplantation?
Fecal Microbiota Transplantation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for unresectable or metastatic advanced pancreatic ductal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Patients must be able to provide written informed consent and understand the infectious risks associated with FMT administration
You likely can't join if
- Previously received cytotoxic chemotherapy with curative or non-curative intent for PDAC
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or...
- 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...
- Presence of a chronic intestinal disease (e.g. Celiac, malabsorption, primary colonic tumor)
See the full eligibility 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...
- 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...
- 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...
- Previously received cytotoxic chemotherapy with curative or non-curative intent for PDAC
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.