NCT03693677: FUNGEMAX

First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI

Completed Phase 2 Last updated 1 July 2025

What this trial tests

Phase 2 trial testing Irinotecan Liposomal Injection in Metastatic Pancreatic Cancer in 288 participants. Completed in 10 January 2025.

Timeline

16 November 2018

Primary endpoint
10 January 2025

10 January 2025

Quick facts

Lead sponsor	Federation Francophone de Cancerologie Digestive
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	288
Start date	16 November 2018
Primary completion	10 January 2025
Estimated completion	10 January 2025
Sites	36 locations across Martinique, France

Drugs / interventions tested

• Irinotecan Liposomal Injection
• 5-FU/LV — full drug profile →
• Nab-Paclitaxel (nab-paclitaxel) — full drug profile →
• Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

• Metastatic Pancreatic Cancer — all drugs for Metastatic Pancreatic Cancer →

Sponsor

Federation Francophone de Cancerologie Digestive — full company profile →

Who can join

Adults 18 to 75, any sex, with Metastatic Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In Europe, pancreatic cancer (PC) is the 7th most common cancer and the 5th leading cause of cancer death in Europe. Each year, the number of deaths due to prostate cancer is almost as high as the number of new cases diagnosed reflecting the poor prognosis associated with this disease. PC is insidious and is often diagnosed late. Despite advances in the management of other more common gastrointestinal cancers, the treatment of PC has had few benefits inherent in recent advances in digestive oncology. Gemcitabine has thus remained the reference treatment for more than 10 years.

Recent studies have shown that gemcitabine/Nab-paclitaxel combination therapy is more effective in PC than gemcitabine-based therapy alone. In addition, multidrug therapy approaches (Irinotecan-5FU/LV) have also emerged to avoid the emergence of resistance to treatments while limiting toxicities. The recently developed Nal-IRI has also shown interesting efficacy in patients with metastatic PC previously treated with gemcitabine, with improved overall survival median and limited toxicity. Based on this information, the NAPOLI trial was conducted in patients with second line PC comparing the efficacy of Nal-IRI/5FU/LV or Nal-IRI and 5FU/LV alone; in this key study, the combination Nal-IRI/5FU/LV treatment was more effective than monotherapies (Nal-IRI or 5FU/LV alone).

Based on all these data, a Phase II trial testing the standard of care gemcitabine/nab-paclitaxel vs Nal-IRI/5FU/LV vs Nal-IRI/5FU/LV 2-months sequential regimen followed by gemcitabine/nab-paclitaxel will be performed. This will allow us to i) know the tolerance and efficacy of Nal-IRI/5FU/LV in the first line of treatment, ii) test a new sequential strategy with Nal-IRI but also iii) compare our results in the experimental arms with one of the two world standard therapeutic regimens: gemcitabine + nab-Paclitaxel. All this in order to improve the management of patients with PC from the first line of treatment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integration of liposomal irinotecan in the first-line treatment of metastatic pancreatic cancer: try to do not think about the white bear.
   Melisi D, Casalino S, Pietrobono S, Quinzii A, et al · · 2024 · cited 5× · PMID 38584763 · DOI 10.1177/17588359241234487
2. Sequential alternation of nal-IRI/5-FU and gemcitabine/nab-paclitaxel versus nal-IRI/5-FU versus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer: results of the randomized phase II PRODIGE 61-FUNGEMAX trial (France).
   Taieb J, Pernot S, Thuillier F, Delattre A, et al · · 2026 · PMID 42256682 · DOI 10.1016/j.eclinm.2026.103998