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Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma

NCT07076212 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-05-06

No results posted yet for this study

Summary

This is a single-center, open-label, randomized Phase 2 trial to evaluate the efficacy of NALIRIFOX (Arm 1) vs mGAP (Arm 2) in previously untreated patients with locally advanced (unresectable) and metastatic pancreatic ductal adenocarcinoma (PDAC).

Conditions

  • Metastatic Pancreatic Adenocarcinoma
  • Locally Advanced Pancreatic Adenocarcinoma

Interventions

DRUG

Liposomal Irinotecan

50 mg/m2 will be administered on Day 1 of a 2-week cycle

DRUG

Oxaliplatin

60 mg/m2 will be administered on Day 1 of a 2-week cycle

DRUG

5-Fluorouracil

5-fluorouracil (2400 mg/m2 over 46 hours) will begin administration on Day 1 of a 2-week cycle

DRUG

Leucovorin

400 mg/m2 will be administered on Day 1 of a 2-week cycle

DRUG

Gemcitabine (mg/m²)

1000 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle

DRUG

Nab-paclitaxel

125 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle

DRUG

Cisplatin

25 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Albert Lockhart, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-02
Primary Completion
2028-05-31
Completion
2029-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07076212 on ClinicalTrials.gov