Oxaliplatin plus irinotecan vs irinotecan as second-line treatment in pancreatic cancer patients: a randomized-controlled open-label Phase II study.

ABSTRACT:

Background

Limited second-line therapeutic options are available for metastasis pancreatic cancer (mPC). We aimed to explore the efficacy and safety of oxaliplatin plus irinotecan (IROX) in mPC patients.

Methods

This is an open-label, Phase 2, randomized study of mPC patients (aged 18-75 years) who failed when using gemcitabine plus S-1 as first-line therapy. Block randomization with a block size of four was used to randomly assign patients (1:1) between October 2015 and December 2017 to receive either IROX (oxaliplatin 85 mg/m² and irinotecan 160 mg/m²) or irinotecan monotherapy (irinotecan 180 mg/m²) until disease progression, unacceptable adverse events, or consent withdrawal. The primary end point was overall survival, and the secondary e

SUBMITTER: Zhang H 

PROVIDER: S-EPMC9897170 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature