New study aims to match pancreatic cancer patients with best chemo
NCT ID NCT04469556
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested two standard chemotherapy regimens, Folfirinox and Gemcitabine/nab-paclitaxel, in 150 patients with untreated metastatic pancreatic cancer. The goal was to see which works better and to use lab tests to personalize treatment. The study is complete, and results may help guide future therapy choices.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Folfirinox and Gemcitabine/nab-paclitaxel (chemotherapy)
- What this could lead to
- If successful, this could help doctors choose the best chemotherapy for each patient with advanced pancreatic cancer, potentially improving survival.
- What could go wrong
- This is a mid-stage trial with 150 participants, so results may not apply to everyone. Chemotherapy has significant side effects, and the study may not show a clear benefit for either drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
150 people
The number who actually took part.
- Started
-
Oct 2020
- Finished
-
Mar 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must have a histological or radiological diagnosis of untreated metastatic PDAC at screening with histology subsequently confirmed prior to randomization. 2. Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma. 3. Patients with a history of prior or concurrent second primary malignancy whose natural history or treatment does not have the potential to interfere with the safety or primary endpoint efficacy assessment of the pancreas cancer should generally be eligible for enrollment in clinical trials. 4. Age ≥18 years. 5. Patient must have a tumor lesion that is amenable to a core needle biopsy. 6. Patients must be suitable for treatment with either mFFX and GA without contraindications to either regimen. 7. Eastern Cooperative Group (ECOG) performance status 0-1. (Karnofsky ≥70%). 8. Life expectancy of greater than 90 days, as judged by the investigator 9. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 10. Within 14 days of the proposed randomization date, patients must have normal organ and marrow function Exclusion Criteria: 1. Patients who have received prior systemic treatment for PDAC, including treatment in the neoadjuvant or adjuvant setting. Prior surgery or palliative radiation is permitted. 2. Patients with histology other than pancreatic ductal adenocarcinoma. Those with adenosquamous are allowed. Acinar tumors and colloid are excluded. 3. Patients with one or more contraindications to tumor biopsy according to local institution's standard biopsy procedures. 4. Patients with known brain metastases are excluded from participation in this clinical study. 5. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inability to stop anticoagulation medication for a biopsy, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. 7. Patients with a known germline mutation in BRCA, PALB2 or other homologous Recombination Repair Deficiency (HRD) genes. 8. Patients who are pregnant or breastfeeding. 9. Use (including 'recreational use') of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirements. \*Use of any illicit drugs or other substance abuse (including alcohol) are not screened in Canada using Toxicity testing. -
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced pancreatic cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
BC Cancer Agency Vancouver
Vancouver, British Columbia, V5Z 1L8, Canada
-
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
-
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
-
Northwell Health
New Hyde Park, New York, 11042, United States
-
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2N9, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a phone app help pancreatic cancer patients eat better during treatment?
- Can a Dietitian's plan help older pancreatic cancer patients feel better?
- Can a vaccine stop GI cancers from returning?
- Triple therapy aims to stall pancreatic cancer
- Can removing more tissue around pancreatic tumors stop cancer from coming back?
- Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?