Pre-surgery NALIRIFOX for borderline resectable pancreatic ductal adenocarcinoma
A Phase 2 Clinical Trial of Nalirifox as Neoadjuvant Treatment for Patients With Borderline Resectable Pancreatic Ductal Adenocarcinoma (Nectar Study)
This phase II study tries NALIRIFOX (liposomal irinotecan plus oxaliplatin, 5‑fluorouracil, and leucovorin) before and after surgery to see if it helps people with borderline resectable pancreatic ductal adenocarcinoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06821997 on ClinicalTrials.gov |
What this trial studies
This single-arm phase II trial gives NALIRIFOX (liposomal irinotecan, oxaliplatin, infusional 5‑fluorouracil, and leucovorin) every 14 days for 4–8 cycles as neoadjuvant therapy to patients with borderline resectable pancreatic ductal adenocarcinoma. Patients undergo surgical resection 4–8 weeks after the last preoperative dose and may receive up to 4 additional cycles of the same regimen starting 4–12 weeks after surgery. Primary endpoints focus on antitumor efficacy, with secondary endpoints examining clinical efficacy, tolerability, and safety, and exploratory objectives include blood- and tumor-based biomarker studies. CT imaging and serial blood/tissue biospecimen collection are used throughout the study to monitor response, resectability, and correlate biomarkers with outcomes.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed borderline resectable pancreatic ductal adenocarcinoma, ECOG performance status 0–1, measurable disease by RECIST 1.1, and adequate blood, liver, and kidney function are ideal candidates.
Not a fit: Patients with metastatic or clearly unresectable disease, poor performance status, or significant organ dysfunction such as low blood counts or impaired liver/kidney function are unlikely to benefit from this regimen.
Why it matters
Potential benefit: If successful, NALIRIFOX could shrink or control tumors before surgery to increase the chance of complete removal and improve long‑term outcomes.
How similar studies have performed: Neoadjuvant FOLFIRINOX has previously increased resection rates in borderline resectable pancreatic cancer and liposomal irinotecan has shown activity in metastatic disease, but combining nal‑IRI with oxaliplatin in the neoadjuvant setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years of age * Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) that is borderline resectable (BR) using the National Comprehensive Cancer Network criteria * Have a documented Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Absolute neutrophil count (ANC) ≥ 1,500 cells/uL without the use of hematopoietic growth factors * Platelet count ≥ 100,000 cells/uL * Hemoglobin ≥ 9 g/dL * Plasma total bilirubin ≤ upper limit of normal (ULN) (biliary drainage is allowed for biliary obstruction) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN * Creatine clearance of \> 30 mL/min (per Cockroft-Gault equation) * Plasma albumin ≥ 3 g/dL * Have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form (ICF) prior to receiving any study related procedure Exclusion Criteria: * Patients who have had previous chemotherapy or radiotherapy for PDAC * Patients with resectable, unresectable, or metastatic PDAC * Presence of germline glucuronosyltransferase (UGT) 1A1 (\*28 or \*6) or dihydropyrimidine dehydrogenase (DPD) polymorphisms (DPYD\*2A \[rs3918290, c.1905+1G\>A, IVS14+1G\>A\], c.2846A\>T \[rs67376798, D949V\], c.1679T\>G \[rs55886062, DPYD\*13, I560S\], and c.1236G\>A \[rs56038477, E412E, in haplotype B3\]) known to significantly impact CPT-11 and fluorouracil metabolism and associated with increased risk for toxicities * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Christos Fountzilas — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.