New chemo cocktail aims to shrink pancreatic tumors
NCT ID NCT07076212
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two chemotherapy regimens for people with advanced pancreatic cancer that has spread or cannot be removed by surgery. One group gets NALIRIFOX (a mix of four drugs) every two weeks, while the other gets a modified version of gemcitabine, nab-paclitaxel, and cisplatin every four weeks. The goal is to see which combination shrinks more tumors. The trial is recruiting 52 adults who have not had prior treatment for their cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy combination (liposomal irinotecan, oxaliplatin, 5-fluorouracil, leucovorin vs gemcitabine, nab-paclitaxel, cisplatin)
- What this could lead to
- If NALIRIFOX works better than the other combo, it could become a new standard treatment for advanced pancreatic cancer, potentially shrinking more tumors and extending life.
- What could go wrong
- This is a small, early Phase 2 trial with only 52 people, so results may not apply to everyone. Chemotherapy has serious side effects, and the new combo might not be more effective than existing options.
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
-
About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2026
- Expected to finish
-
Nov 2029
An estimate. End dates often move.
- 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: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥18 years * For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and agreement to use such a method during study participation and for an additional 9 months after the end of the last dose of study medication administration * Female patients including WOCBP must test negative for pregnancy at the time of screening based on a urine or serum pregnancy test. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner during the study and for 4 months after the last dose of study medication. * Histologically or cytologically confirmed locally advanced or metastatic PDAC that has not been previously treated * Radiographically confirmed measurable (per RECIST 1.1) locally advanced or metastatic PDAC per the National Comprehensive Cancer Network (NCCN) definition. * Inoperable status due to the presence of locally advanced, unresectable disease with or metastases. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Hematological, biochemical, and organ function inclusion criteria: * Absolute neutrophil count (ANC) ≥1500/mm3 without the use of hemopoietic growth factors within 7 days before treatment * Platelet count ≥100,000/mm3. * International normalized ratio (INR) \<1.5 unless the patient is receiving anticoagulation therapy, in which case a therapeutic INR is acceptable. Anticoagulation therapy with low-molecular weight heparin or warfarin, whether medically indicated, is permitted. * Adequate renal function, as evidenced by serum/plasma creatinine level \<1.6 mg/dL Exclusion Criteria: * Pregnancy or lactation * Treatment with another investigational drug or other intervention within 30 days of protocol initiation. * Known hypersensitivity/allergic reaction to any of the components of the therapeutic agents in mGAP or NALIRIFOX. * Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, and participate in the study or who is likely to interfere with the interpretation of the results. * Unwilling or unable to comply with study procedures and/or study visits. * Uncontrolled, active infection * Histologic diagnosis other than adenocarcinoma. * Medical co-morbidities, that preclude major abdominal surgery
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Locally advanced pancreatic adenocarcinoma 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hollings Cancer Center at Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
-
Medical University of South Carolina Hollings Cancer Center
RECRUITINGCharleston, South Carolina, 29425, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo tested against aggressive pancreatic cancer
- Can a Two-Drug immune attack shrink Hard-to-Treat pancreatic tumors?
- Can a targeted antibody give pancreatic cancer chemo a boost?
- Can High-Dose vitamin c boost chemo against pancreatic cancer?
- Four-Drug cocktail aims to shrink pancreatic tumors before surgery
- Could a nerve zap stop cancer wasting? early trial tests device for cachexia