Recruiting
Phase 2

NalirifoX vs. mGAP

Sponsor:

Medical University of South Carolina

Code:

NCT07076212

Conditions

Metastatic Pancreatic Adenocarcinoma

Locally Advanced Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liposomal Irinotecan

Oxaliplatin

5-Fluorouracil

Leucovorin

Gemcitabine (mg/m²)

Study Details

Brief 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

Study ID

NCT07076212

Start date

Apr 2, 2026

Status verified date

May, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged ≥18 years
  • For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and agreement to use such a method during study participation and for an additional 9 months after the end of the last dose of study medication administration
  • Female patients including WOCBP must test negative for pregnancy at the time of screening based on a urine or serum pregnancy test.
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner during the study and for 4 months after the last dose of study medication.
  • Histologically or cytologically confirmed locally advanced or metastatic PDAC that has not been previously treated
  • Radiographically confirmed measurable (per RECIST 1.1) locally advanced or metastatic PDAC per the National Comprehensive Cancer Network (NCCN) definition.
  • Inoperable status due to the presence of locally advanced, unresectable disease with or metastases.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Hematological, biochemical, and organ function inclusion criteria:

  • Absolute neutrophil count (ANC) ≥1500/mm3 without the use of hemopoietic growth factors within 7 days before treatment
  • Platelet count ≥100,000/mm3.
  • International normalized ratio (INR) <1.5 unless the patient is receiving anticoagulation therapy, in which case a therapeutic INR is acceptable. Anticoagulation therapy with low-molecular weight heparin or warfarin, whether medically indicated, is permitted.
  • Adequate renal function, as evidenced by serum/plasma creatinine level <1.6 mg/dL

Exclusion Criteria:

  • Pregnancy or lactation
  • Treatment with another investigational drug or other intervention within 30 days of protocol initiation.
  • Known hypersensitivity/allergic reaction to any of the components of the therapeutic agents in mGAP or NALIRIFOX.
  • Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, and participate in the study or who is likely to interfere with the interpretation of the results.
  • Unwilling or unable to comply with study procedures and/or study visits.
  • Uncontrolled, active infection
  • Histologic diagnosis other than adenocarcinoma.
  • Medical co-morbidities, that preclude major abdominal surgery

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NALIRIFOX

experimental: mGAP

Interventions

Liposomal Irinotecan

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

Oxaliplatin

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

5-Fluorouracil

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

Leucovorin

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

Gemcitabine (mg/m²)

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

Nab-paclitaxel

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

Cisplatin

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

HCC Clinical Trials Office, MD

843-792-9321hcc-clinical-trials@musc.edu

Locations

Hollings Cancer Center at Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

HCC Clinical Trials Office

843-792-9321hcc-clinical-trials@musc.edu

Principal Investigator:

Albert Lockhart, MD

Medical University of South Carolina Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

HCC Clinical Trials Office

843-792-9321hcc-clinical-trials@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-05-06.