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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07076212
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Locally Advanced Pancreatic Adenocarcinoma
  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Irinotecan — DRUG
    50 mg/m2 will be administered on Day 1 of a 2-week cycle
  • Oxaliplatin — DRUG
    60 mg/m2 will be administered on Day 1 of a 2-week cycle
  • 5-Fluorouracil — DRUG
    5-fluorouracil (2400 mg/m2 over 46 hours) will begin administration on Day 1 of a 2-week cycle
  • Leucovorin — DRUG
    400 mg/m2 will be administered on Day 1 of a 2-week cycle
  • Gemcitabine (mg/m²) — DRUG
    1000 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle
  • Nab-paclitaxel — DRUG
    125 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle
  • Cisplatin — DRUG
    25 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle

Study Details

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).

Key Dates

Start date
Apr 2, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NALIRIFOX
  • Experimental: mGAP

Primary Outcome Measure

Overall response rate (ORR) assessed by imaging. [ Time Frame: Up to 30 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hollings Cancer Center at Medical University of South CarolinaCharlestonSouth Carolina29425
HCC Clinical Trials Office
[email protected]
843-792-9321
Albert Lockhart, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina Hollings Cancer CenterCharlestonSouth Carolina29425
HCC Clinical Trials Office
[email protected]
843-792-9321

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By research site
Hollings Cancer Center at Medical University of South Carolina· Charleston, SCMedical University of South Carolina Hollings Cancer Center· Charleston, SC

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