Actively Recruiting
Nalirifox as Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma (Nectar Study)
Led by Roswell Park Cancer Institute · Updated on 2026-04-01
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how well a combination of chemotherapy drugs called NALIRIFOX works before surgery in patients with borderline resectable pancreatic ductal adenocarcinoma. This phase II trial aims to assess the treatment's ability to shrink tumors and improve surgical outcomes, as well as to evaluate its safety and identify biomarkers related to patient outcomes. The study is sponsored by Roswell Park Cancer Institute. Participants receive NALIRIFOX, which includes liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil, given through intravenous infusions. Treatment cycles occur every 14 days for 4 to 8 cycles before surgery. Surgery to remove the tumor is scheduled 4 to 8 weeks after the last treatment. Starting 4 to 12 weeks post-surgery, patients may receive up to 4 more cycles of NALIRIFOX if their disease does not progress or if side effects are manageable. Throughout the study, patients undergo CT scans and blood sample collections. During participation, patients are closely monitored with imaging and laboratory tests to evaluate treatment effects and safety. After completing the treatment phases, follow-up visits occur within 30 days, then every 3 to 6 months for 2 years, and subsequently every 6 to 12 months for up to 5 years. Researchers will assess major pathologic response, survival rates, disease progression, and adverse events to understand the treatment's impact over time.
CONDITIONS
Brief Title
NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed borderline resectable pancreatic ductal adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count of at least 1,500 cells/uL without growth factors
- Platelet count of at least 100,000 cells/uL
- Hemoglobin level of at least 9 g/dL
- Plasma total bilirubin less than or equal to the upper limit of normal (biliary drainage allowed)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 times the upper limit of normal
- Creatinine clearance greater than 30 mL/min
- Plasma albumin level of at least 3 g/dL
- Measurable or evaluable disease per RECIST 1.1 criteria
- Agreement to use effective contraception if of child-bearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Previous chemotherapy or radiotherapy for pancreatic ductal adenocarcinoma
- Resectable, unresectable, or metastatic pancreatic ductal adenocarcinoma
- Presence of specific genetic polymorphisms (UGT 1A1 *28 or *6, DPYD variants) that increase treatment toxicity risk
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric illness
- Pregnant or nursing women
- Unwillingness or inability to follow the study protocol
- Any condition making the participant unsuitable for study drug in the opinion of the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 to 16 weeks
Participants receive liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil intravenously every 14 days for 4 to 8 cycles, in the absence of disease progression or unacceptable toxicity.
Every 2 weeks for 4 to 8 cycles (in-person)
Duration - 4 to 8 weeks
Participants undergo surgical resection 4 to 8 weeks after completing initial treatment.
1 surgical procedure visit plus immediate post-operative care
Duration - Up to approximately 8 weeks
Starting 4 to 12 weeks after surgery, participants receive up to 4 additional cycles of liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil intravenously every 14 days if there is no disease progression or unacceptable toxicity.
Every 2 weeks for up to 4 cycles (in-person)
Duration - Up to 5 years
After completing all study treatments, participants are followed up within 30 days, then every 3 to 6 months for 2 years, followed by every 6 to 12 months for up to 5 years to monitor health and outcomes.
Regular visits every 3 to 6 months for 2 years, then every 6 to 12 months up to 5 years
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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