A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)

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.

Safety/toxicity and tolerability profil: Severety of adverse events

Adverse events and Serious Adverse events will be assessed during the study treatment and until 14 days later. Severety will be graded according to the NCI-CTCAE version 5.0 and relationship to the study medication will be defined.

Safety/toxicity and tolerability profil: Laboratory assessments

Standard laboratory safety assessments: They are mandatory prior to each administration of study medication and at the 15 days follow-up visit. Clinically significant vs not clinically significant.

Safety/toxicity and tolerability profil: ECOG

WHO ECOG performance status (PS) will be defined prior to each administration of study medication and at the 15 days follow-up visit following the ECOG Performance Status Scale.

Safety/toxicity and tolerability profil: review of body systems

A full review of body systems will be performed: heart rate, blood pressure, respiratory rate, body temperature, height, weight and ECG (screening visit only, unless clinically indicated). Clinically significant versus not clinically significant

Exploratory lab investigation for potential prognostic and predictive biomarkers on blood and tumor samples

Translational research will be performed for potential prognostic and predictive biomarkers. For that purpose, plasma samples will be kept in the selected centres' biobanks. The translational research will be carried out on tumor samples collected before the start of treatment and on blood samples collected as per below. Tumor tissue: 10 slices of the paraffin embedded tissue collected during the diagnosis of the disease will be collected. Blood samples: Two 10 ml blood samples from each patient who consents to participate in the biological study will be collected before the start of the treatment, and before each cycle till the discontinuation of the treatment. The exact measurements that will be done, have not been defined yet.