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

NCT07076212 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 103973
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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

Locally Advanced Pancreatic Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) assessed by imaging.

  Overall response rate (ORR) defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by imaging completed every 8 weeks.

  Up to 30 months

Secondary Outcomes (6)

• Best overall response (BOR) assessed by imaging.

  Up to 30 months

• Duration of response (DOR).

  Up to 30 months

• Disease control rate (DCR).

  Up to 30 months

• Progression-free survival (PFS).

  Up to 30 months

• Overall survival (OS).

  Up to 30 months

Study Arms (2)

NALIRIFOX

EXPERIMENTAL

Drug: Liposomal Irinotecan; Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Leucovorin

mGAP

EXPERIMENTAL

Drug: Gemcitabine (mg/m²); Drug: Nab-paclitaxel; Drug: Cisplatin

Interventions

Liposomal Irinotecan DRUG

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

NALIRIFOX

Oxaliplatin DRUG

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

NALIRIFOX

5-Fluorouracil DRUG

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

NALIRIFOX

Leucovorin DRUG

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

NALIRIFOX

Gemcitabine (mg/m²) DRUG

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

mGAP

Nab-paclitaxel DRUG

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

mGAP

Cisplatin DRUG

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

mGAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (2)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Interventions

irinotecan sucrosofate; Oxaliplatin; Fluorouracil; Leucovorin; Gemcitabine; 130-nm albumin-bound paclitaxel; Cisplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Albert Lockhart, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HCC Clinical Trials Office, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: April 2, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)