Actively Recruiting
Monthly Alternating NALIRIFOX and GnP in the First-Line Setting for Metastatic Pancreatic Ductal Adenocarcinoma
Led by Northwell Health · Updated on 2026-03-18
41
Participants Needed
7
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, interventional, single-center, single-arm, open-label, phase II study for patients with metastatic pancreatic cancer. The intervention consists of monthly alternating standard chemotherapy regimens-NALIRIFOX and GnP. The hypothesis is that induction therapy with alternating NALIRIFOX and GnP has better efficacy compared to historical observation.
CONDITIONS
Official Title
Monthly Alternating NALIRIFOX and GnP in the First-Line Setting for Metastatic Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older than 18 years of age
- Histologically confirmed pancreatic ductal adenocarcinoma, poorly differentiated carcinoma, or adenosquamous carcinoma
- Radiographic proof of metastatic disease
- At least one measurable target lesion according to RECIST 1.1 criteria
- Metastatic relapse allowed if more than 6 months have passed since last standard adjuvant treatment
- ECOG performance status of 0 or 1
- Laboratory results within 14 days meeting: hemoglobin > 9.0 g/dL (transfusion allowed before enrollment if lower), platelet count > 100 x 10^9/L, absolute neutrophil count > 1.5 x 10^9/L, total bilirubin less than 3 times upper limit of normal, AST and ALT less than 3 times upper limit of normal (or less than 5 times if liver metastases present), creatinine ≤ 1.5 times upper limit of normal, creatinine clearance > 40 mL/min, APTT ≤ 1.5 times upper limit of normal (with exceptions for heparin use), PT/INR ≤ 1.5 times upper limit of normal (with exceptions for warfarin use)
- Women of childbearing potential must be surgically sterile, postmenopausal, or have a negative pregnancy test and use effective barrier contraception or abstinence during treatment
- Male patients must be surgically sterile or use effective contraception or abstinence during treatment
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Any other disease, metabolic dysfunction, clinical findings, or lab results that may pose safety risks or affect study results as judged by the investigator
- Histology of ampullary, acinar, squamous, or neuroendocrine carcinoma
- Presence of metastases in the central nervous system
- Life expectancy less than 12 weeks
- Pregnant or breastfeeding women
- Prior neuropathy greater than grade 1 by CTCAE v5
- History or symptoms of cardiac disease requiring New York Heart Association Functional Classification worse than class 2B
- Major surgery within 4 weeks before starting study treatment without full recovery
- Any previous chemotherapy for metastatic pancreatic cancer
- Known BRCA1, BRCA2, or PALB2 gene mutations
- Active second cancer likely to impact survival
- Any medical or social condition that may interfere with consent, cooperation, participation, or study interpretation
- Unwillingness or inability to comply with study procedures including long-term follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Imbert Cancer Center
Bay Shore, New York, United States, 11706
Actively Recruiting
2
Northern Westchester Cancer Center
Mount Kisco, New York, United States, 10549
Actively Recruiting
3
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
4
Zuckerberg Cancer Center
New Hyde Park, New York, United States, 11042
Actively Recruiting
5
Manhattan Eye, Ear and Throat Hospital
New York, New York, United States, 10065
Actively Recruiting
6
NHPP Medical Oncology at Rego Park
Rego Park, New York, United States, 11374
Actively Recruiting
7
Phelps Cancer Center
Sleepy Hollow, New York, United States, 10591
Actively Recruiting
Research Team
G
GI Trial Referral
CONTACT
L
Lalta Dhanantwari, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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