The study of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma

The research company Belgian Group of Digestive Oncology is conducting the clinical trial A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC) (NALPAC).

It is planned to include 134 participants.

Actual study start date is May 25, 2022. The researchers expect to complete the study by December 31, 2027.

One primary outcome measure is Efficacy of NALIRINOX and NALIRI through Progression-Free Survival at D85, NALIRINOX is the investigational arm and NALIRI is the standard care arm. The efficacy will be assessed in terms of the Progression-Free Survival Rate (PFSR). This is defined as the proportion of patients alive and free of progression at day 85.

Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05472259.