Monthly Alternating NALIRIFOX and GnP in the First-Line Setting

Not Applicable

Recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Drug: NALIRIFOX; Drug: Gemcitabine plus nab-Paclitaxel (GnP)

• Registration Number: NCT07163273
• Lead Sponsor: Northwell Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-20
• Study First Submitted: 2025-07-14
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Primary Completion: 2027-06-20
• Study Completion: 2027-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NALIRIFOX	NALIRIFOX	NALIRIFOX consists of 5-FU 2400 mg/m2 over 46 hours, liposomal irinotecan 50 mg/m2, and oxaliplatin 60 mg/m2, which would be given on Day 1 and Day 15
Gemcitabine plus nab-Paclitaxel (GnP)	Gemcitabine plus nab-Paclitaxel (GnP)	GnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.

Primary Outcome Measures

Name	Time	Method
Determine 6-month Progression Free Survival (PFS)	6 months	The primary endpoint is 6-month PFS rate defined as the proportion of patients alive and progression free (by RECIST v.1.1) at 6 months after treatment initiation. PFS events will be classified as either local progression, distant recurrence, secondary malignancy, or death.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	24 months	Overall response rate, defined as the proportion of patients whose best response is partial response or complete response by RECIST v.1.1
Disease Control Rate	24 months	Disease control rate, defined as the proportion of patients whose best response is stable disease, partial response, or complete response, by RECIST v.1.1
Determine Toxicities using the NCI CTCAE v. 5.0	24 months	AEs will be monitored, and the incidence, severity, and relationship to study drug will be reported.
Overall Survival	24 months	OS, defined as the time from treatment initiation to death. Patients living without disease progression will be censored at the date of last assessment
Time to Treatment Failure	24 months	Time to treatment failure, defined as the time from treatment initiation to discontinuation of treatment, either due to progression or intolerance

Trial Locations

Locations (1)

Zuckerberg Cancer Center; 🇺🇸 New Hyde Park, New York, United States