New cocktail aims to shrink pancreatic tumors before surgery
NCT ID NCT05851924
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 5 times
Summary
This phase 2 trial tests whether giving a powerful chemotherapy regimen called NALIRIFOX along with targeted radiation and the drug capecitabine can shrink pancreatic tumors enough to allow successful surgery. The study enrolls 60 people with borderline resectable or locally advanced pancreatic cancer. Researchers will track how long patients live without the cancer progressing or returning, and how the treatment affects their quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NALIRIFOX (a combination of liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil) plus capecitabine and radiation therapy
- What this could lead to
- If successful, this approach could make more pancreatic tumors removable by surgery and improve how long patients live without the cancer coming back.
- What could go wrong
- This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. The chemotherapy and radiation combination can cause significant side effects.
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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2023
- Expected to finish
-
Sep 2027
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: 1. Subject has been informed about the nature of the study, has agreed to participate in the study, and has signed the informed consent form before participation in any study-related activities. 2. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, DCIS, stage I prostate cancer, and basal cell or squamous cell carcinoma of the skin. 3. A multidisciplinary discussion has been undertaken/planned which can include (a) discussion with medical/surgery oncology, (b) Hepatopancreaticobiliary Disease Management Team conference presentation, (c) direct consultation, with confirmation on consensus plan for TNT strategy and potential for future surgery. This plan needs to be documented in the medical record prior to initiation of treatment. 4. Male or nonpregnant and nonlactating female aged ≥18 years. 1. Women of child-bearing potential (i.e., fertile, following menarche, and until becoming postmenopausal unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) must test negative for pregnancy at the time of screening on the basis of a urine or serum pregnancy test. Postmenopausal women are defined as those who have had an absence of menstruation for at least 2 years. If necessary, follicle-stimulating hormone results \>50 IU/L at screening are confirmatory in the absence of a clear postmenopausal history. 2. Female subjects of reproductive potential must agree to use two effective methods of birth control during the study and for 9 months after the last dose of study medication. 3. Male subjects must agree to use condoms during the study and for 4 months after the last dose of study medication' Disease-specific inclusion criteria: 1. Histologically or cytologically confirmed PDAC that has not been previously treated. 2. Radiographically BR or LA PDAC in accordance with the NCCN 2.2021 definition, without evidence of distant metastases by CT. 3. Inoperable status after surgical exploration due to presence of locally advanced, unresectable disease without metastases, in patients who have recovered from surgery, is allowed. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Hematological, biochemical, and organ function inclusion criteria: 1. Absolute neutrophil count (ANC) ≥1500/mm\^3 without the use of hemopoietic growth factors within 7 days before treatment 2. Platelet count ≥100,000/mm\^3 . 3. 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-molecularweight heparin or warfarin, whether medically indicated, is permitted. 4. Adequate renal function, as evidenced by serum/plasma creatinine level \<1.6 mg/dL Exclusion Criteria: 1. Presence of metastatic pancreatic cancer (M1 disease) 2. 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. 3. Unwilling or unable to comply with study procedures and/or study visits. 4. Medical co-morbidities, that preclude major abdominal surgery 5. Histologic diagnosis other than adenocarcinoma; however, adenosquamous variants are acceptable. 6. Receipt of chemotherapy, prior abdominal radiotherapy, and/or definitive resection for pancreatic cancer. 7. Grade \>2 neuropathy. 8. Pregnant and/or nursing. 9. Uncontrolled active infection, which would preclude with the exception of resolving cholangitis which in the investigator opinion would render the treatment hazardous. 10. Known hypersensitivity to any of the components of the chemotherapeutic agents 11. Receipt of concurrent investigational therapy or within 30 days of protocol initiation. Additional criterion for the immunoPET imaging sub-study (n=20) 12. Previous anaphylactic reaction to human, humanized or chimeric antibody. 13. Refusal or inability to tolerate the scanning procedure (e.g. due to claustrophobia).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pancreatic ductal 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
7 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
-
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
-
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
-
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
-
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
-
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
-
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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 new drug shrink advanced solid tumors?