Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	6-month progression-free survival (PFS) rate post randomization Step 1 (R1) in Arm 1A	6 months	To assess the efficacy of a 6-month PFS rate post R1 in patients with metastatic PDAC who received first-line (L1) NALIRIFOX with LV5FU2 (5-FU/leucovorin) maintenance strategy during Step 1 (Arm 1A).
Secondary	Progression-free survival first-line (PFS-L1) post randomization Step 1 (R1) in Arm 1A and in Arm 1B	up to 5 years	To assess PFS-L1 post R1 in Arm 1A and Arm 1B
Secondary	Progression-free survival (PFS) post NALIRIFOX reintroduction (PFS-reintro) in Arm 1A	up to 5 years	To assess PFS-reintro in Arm 1A
Secondary	Overall survival post randomization Step 1 (OS-R1) in Arm 1A and in Arm 1B	up to 5 years	To assess OS-R1 in Arm 1A and Arm 1B
Secondary	Overall response rate of first-line (ORR-L1) at 4 months in Arm 1A and in Arm 1B	4 months	To assess ORR-L1 at 4 months in Arm 1A and Arm 1B, according to RECIST 1.1
Secondary	Overall response rate post NALIRIFOX reintroduction (ORR-RI) in Arm 1A	up to 5 years	To assess ORR-RI in Arm 1A
Secondary	Best response rate of first-line (BRR-L1) in Arm 1A and in Arm 1B	up to 5 years	To assess BRR-L1 in Arm 1A and Arm 1B
Secondary	Best response rate of first-line after reintroduction of NALIRIFOX (BRR-L1R) in Arm 1A	up to 5 years	To assess BRR-L1R in Arm 1A
Secondary	Duration of disease control (DDC) in Arm 1A and in Arm 1B	up to 5 years	To assess DDC in Arm 1A and in Arm 1B
Secondary	Grade 3-4 adverse events (AEs)/serious AEs (SAEs) related to treatment	until 28 days after end of treatment visit	To assess safety (only grade 3-4 AEs/SAEs related to treatment in Arm 1A and Arm 1B, according to the NCI CTCAE v5.0
Secondary	Rate of peripheral neuropathy in Arm 1A and Arm 1B	up to 5 years	To assess the rate of peripheral neuropathy (all grade and severe \[grade 3-5\] adverse events \[AEs\] in Arm 1A and Arm 1B, according to NCI CTCAE v5.0
Secondary	Health-related quality of life (HRQoL) by EORTC QLQ-C3 in Arm 1A and in Arm 1B	up to 5 years	To assess HRQoL in Arm 1A and Arm 1B using EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 is a 30-item, tumor-specific, patient-based questionnaire designed for self-administration. The form scores range from 0 to 100. Higher scores indicated worse symptomatic problems.
Secondary	Health-related quality of life (HRQoL) by EORTC QLQ-PAN26 in Arm 1A and in Arm 1B	up to 5 years	To assess HRQoL in Arm 1A and Arm 1B using EORTC QLQ-PAN26 questionnaire. The EORTC QLQ-PAN26 is a module specific to pancreatic cancer, to be used in conjunction to the EORTC QLQ-C30. It contains 26 items. As for the EORTC QLQ-C30, one score is generated for each item, in order that a high score represents a high functional level and a high symptomatic level. Estimated duration: 10 min.
Secondary	6-month progression-free survival (PFS) post randomization (R1) of standard NALIRIFOX in Arm 1B	6 months	To assess a 6-month PFS post R1 of standard NALIRIFOX in Arm 1B

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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