NALIRIFOX vs mGAP for Pancreatic Cancer

Overseen By Toros Dincman, M.D., Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Disqualifiers: Pregnancy, Infection, Other cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 28-day cycles, up to 30 months

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new treatment options for pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body. The treatments under study are NALIRIFOX (a combination of cancer-fighting drugs, including liposomal irinotecan) and mGAP, which also includes a combination of cancer-fighting drugs. Researchers aim to determine which treatment is more effective. Individuals who have not received prior treatment for advanced pancreatic cancer might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulation therapy, it is allowed as long as it is medically indicated.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NALIRIFOX, which includes a form of irinotecan, has promising safety results. In one study, patients treated with NALIRIFOX lived longer than those on another common treatment, suggesting that many patients with pancreatic cancer can tolerate it. However, like most cancer treatments, side effects can occur, though the study did not report any severe ones.

For the mGAP treatment, which combines nab-paclitaxel, gemcitabine, and cisplatin, positive safety data also exist. A study demonstrated that this combination helped patients live longer and had a 71% response rate, indicating it worked well for many. This suggests the treatment is generally well-tolerated, though patients might still experience common chemotherapy side effects.

Both treatments remain under study, but current evidence suggests they are safe enough to consider for those who qualify for the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the NALIRIFOX and mGAP treatments for pancreatic cancer because they offer new combinations and delivery methods that differ from standard treatments. NALIRIFOX combines liposomal irinotecan with other chemotherapy agents, enhancing drug delivery and potentially improving effectiveness by allowing the drug to stay in the body longer and target cancer cells more efficiently. On the other hand, mGAP includes nab-paclitaxel, which helps to disrupt cancer cell growth with a unique formulation that may improve penetration into tumors. These innovations could lead to better outcomes for patients compared to traditional options like FOLFIRINOX or gemcitabine with nab-paclitaxel.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

This trial will compare two treatment options for pancreatic cancer: NALIRIFOX and mGAP. Research has shown that NALIRIFOX, a combination of liposomal irinotecan and other drugs, yields promising results for treating pancreatic cancer. Studies indicate it is effective, with manageable side effects. Even at lower doses, patients experienced good results, suggesting that the treatment can be adjusted without losing effectiveness.

Meanwhile, mGAP, which includes nab-paclitaxel, gemcitabine, and cisplatin, has demonstrated significant improvements in survival rates for pancreatic cancer patients. One study found a 31% reduction in the risk of disease progression or death. Another study reported a 71% response rate, with some patients living more than a year. Both treatment options in this trial have shown potential in improving outcomes for this challenging cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Toros Dincman, M.D., Ph.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for patients with advanced pancreatic cancer who haven't been treated before. It's not clear what specific criteria participants must meet or avoid to join the study, as the eligibility details are missing.

Inclusion Criteria

Provision of signed and dated informed consent form

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

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NALIRIFOX or mGAP regimen for pancreatic adenocarcinoma

28-day cycles, up to 30 months

Day 1 and Day 15 of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term monitoring

Participants are assessed for overall response rate and other secondary outcomes

Up to 30 months

What Are the Treatments Tested in This Trial?

Interventions

• Cisplatin
• Gemcitabine
• Liposomal Irinotecan
• Nab-paclitaxel

Trial Overview The trial compares two treatments: NALIRIFOX (a combination of drugs including 5-Fluorouracil, Oxaliplatin, Liposomal Irinotecan, and Leucovorin) versus mGAP (modified Gemcitabine, Nab-Paclitaxel and Cisplatin).

How Is the Trial Designed?

Group I: mGAP Experimental Treatment 3 Interventions

Group II: NALIRIFOX Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e16447

A phase II study of NALIRIFOX (liposomal irinotecan, 5- ... Conclusions: NALIRIFOX regimen demonstrated promising conversion efficacy with a manageable safety profile in LAPC pts. Further evaluation of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11871866/

Outcomes of Liposomal Irinotecan With 5‐FU and ... This study investigated the effectiveness and safety of liposomal irinotecan plus 5-fluorouracil (5-FU) and leucovorin (LV) as a second-line ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0959804921001957

First-line liposomal irinotecan with oxaliplatin, 5- ... This open-label, phase I/II study evaluated safety and efficacy for first-line liposomal irinotecan + oxaliplatin + 5-fluorouracil + leucovorin (NALIRIFOX).

4. targetedonc.com targetedonc.com/view/nalirifox-dose-reductions-maintain-efficacy-in-pancreatic-cancer

NALIRIFOX Dose Reductions Maintain Efficacy in ... [With NALIRIFOX], patients who had dose reduction did better. Patients who had dose reductions when the liposomal irinotecan was dose reduced; ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03861702

Liposomal Irinotecan in Combination With Oxaliplatin ... This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.4006

and 18-month survival rates from the phase 3 NAPOLI 3 trial. First-line NALIRIFOX demonstrated clinically meaningful and statistically significant improvement in OS and PFS compared with Gem+NabP in patients with mPDAC.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04083235

NCT04083235 | A Study to Assess the Effectiveness and ... The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer ...

8. esmoopen.com esmoopen.com/article/S2059-7029(25)01403-6/fulltext

Health-related quality of life and performance status with ... In the phase III NAPOLI 3 trial, liposomal irinotecan plus 5-fluorouracil/leucovorin plus oxaliplatin (NALIRIFOX) demonstrated significant and ...

9. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(23)01366-1/fulltext

NALIRIFOX versus nab-paclitaxel and gemcitabine in ... The findings of this study support the use of the NALIRIFOX regimen as a new possible standard of care and reference regimen for the first-line ...