NCT05851924 · Memorial Sloan Kettering Cancer Center
A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC)
What this study is about
The researchers are doing this study to find out whether using the chemotherapy regimen NALIRIFOX in combination with ablative dose radiation therapy (AD-XRT) and the standard chemotherapy drug capecitabine is an effective treatment approach for people with locally advanced or borderline resectable pancreatic ductal adenocarcinoma (PDAC) before surgery.
View original scientific description
The researchers are doing this study to find out whether using the chemotherapy regimen NALIRIFOX in combination with ablative dose radiation therapy (AD-XRT) and the standard chemotherapy drug capecitabine is an effective treatment approach for people with locally advanced or borderline resectable pancreatic ductal adenocarcinoma (PDAC) before surgery. This type of treatment approach is called total neoadjuvant therapy (TNT).
Interventions
DRUG
NALIRIFOX
Patients will receive NALIRIFOX for a total of 4 months. NALIRIFOX will be administered on days 1 and 15 of a 4-week cycle for 4 cycles until completion of therapy, intolerable toxicity, or until the development of criteria for removal from the study. Liposomal irinotecan: 50 mg/m2 IV over the course of 90 minutes (±10 minutes) on days 1 and 15 of every 4-week cycle. Oxaliplatin: 60 mg/m2 IV over the course of 120 minutes (±10 minutes) on days 1 and 15 of every 4-week cycle. Leucovorin: 400 mg/m2 IV over the course of 30 minutes (±5 minutes) on days 1 and 15 of every 4-week cycle. 5-FU: 2400 mg/m2 IV over the course of 48 hours (or until the infusion is complete) on days 1 and 15 of every 4-week cycle
COMBINATION_PRODUCT
AD-XRT and Capecitabine
The interval between completion of induction chemotherapy and initiation of AD-XRT will be 2-6 weeks. The patient will be concurrently treated with capecitabine (1000-1500 mg flat BID PO Monday to Friday) with radiation, as per standard dosing regimens at MSK.
Primary outcome measures
event-free survival (EFS)
Time frame: up to 16 weeks
events defined as: 1) progression \[local or systemic progression, per RECIST\], 2) recurrence \[recurrent disease following resection\], or 3) death due to any cause
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 medica
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Collaborators
Ipsen, Pancreatic Cancer Research Fund
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations