New chemo combo strategy aims to outsmart pancreatic cancer
NCT ID NCT07163273
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a new approach for people with metastatic pancreatic cancer: alternating two standard chemotherapy regimens every month instead of using just one. The goal is to see if this switching strategy can keep the cancer from growing for at least 6 months. About 41 participants will receive both NALIRIFOX and gemcitabine/nab-paclitaxel in a monthly rotation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy (NALIRIFOX and gemcitabine/nab-paclitaxel)
- What this could lead to
- If it works, this could offer a new way to slow tumor growth and extend the time before pancreatic cancer worsens.
- What could go wrong
- This is a small, early-phase trial with only 41 people, so results may not apply widely. Chemotherapy side effects can be severe.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 41 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * \>18 years of age * Histologically proven pancreatic ductal adenocarcinoma, poorly differentiated carcinoma, or adenosquamous carcinoma * Radiographic evidence of metastatic disease * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Metastatic relapse of previously resected pancreatic cancer is allowed provided the patient is more than 6 months from last SOC adjuvant treatment * ECOG PS 0-1 * Laboratory assessments within 14 days as indicated below: * Hemoglobin \> 9.0 g/dL (patients with hemoglobin \< 9 g/dL may be transfused prior to study enrollment) * Platelet count \> 100 x 10\^9/L * Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L * Total bilirubin \< 3 x upper limit of normal (ULN) * Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3 x ULN (if liver metastases are present, AST and ALT \< 5 x ULN is permitted. * Creatinine ≤1.5 ULN * Creatinine clearance \> 40 mL/min as calculated by Cockcroft-Gault formula * APTT (aPTT) ≤ 1.5 × ULN. For subjects receiving unfractionated heparin \< 2.5 × ULN, or within acceptable range considered by the investigator. * PT/INR INR ≤ 1.5 × ULN. For subjects receiving warfarin, 2.0 -3.0, or within acceptable range considered by the investigator. * Women of childbearing potential must be surgically sterile or postmenopausal or must have a negative pregnancy test (serum or urine) prior to study enrolment and must use effective barrier contraception or abstinence during the treatment period. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions and therefore are not considered effective for this study. Male patients must be surgically sterile or use effective contraception or abstinence during the treatment period. The definition of effective contraception will be based on investigator discretion. Female and male patients are advised to use effective contraceptives for at least 9 months after the last treatment dose. * Ability to understand and willing to sign informed consent form Exclusion: * A history of other disease, metabolic dysfunction, physical examination finding or clinical laboratory test result suspicious of a disease or condition which, in the opinion of the investigator, would compromise patient safety due to risk of treatment complications or could affect interpretation of the study results * Ampullary, acinar, squamous, and neuroendocrine histology * Presence of central nervous system metastases * Life expectancy \< 12 weeks * Pregnant or breastfeeding women * Prior neuropathy \> grade 1 as per CTCAE v5 * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. * Major surgery within 4 weeks prior to initiation of the study treatment, without full recovery * Any past chemotherapy delivered for metastatic pancreatic cancer * Known somatic or germline mutations in BRCA1, BRCA2, or PALB2 * Active second malignancy whose prognosis has a high likelihood of impacting survival * 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 interfere with the interpretation of the results. Patients also unwilling or unable to comply with study procedures and/or study visits, including long-term follow-up for survival.
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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.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Imbert Cancer Center
RECRUITINGBay Shore, New York, 11706, United States
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Long Island Jewish Medical Center
RECRUITINGNew Hyde Park, New York, 11040, United States
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Manhattan Eye, Ear and Throat Hospital
RECRUITINGNew York, New York, 10065, United States
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NHPP Medical Oncology at Rego Park
RECRUITINGRego Park, New York, 11374, United States
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Northern Westchester Cancer Center
RECRUITINGMount Kisco, New York, 10549, United States
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Phelps Cancer Center
RECRUITINGSleepy Hollow, New York, 10591, United States
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Zuckerberg Cancer Center
RECRUITINGNew Hyde Park, New York, 11042, United States
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Other studies related to the condition(s) this trial covers.
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- 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?