Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients

This is a single-centre, non-randomized, open label phase II trial to be conducted at the National Cancer Centre, Singapore (NCCS). Patients diagnosed with metastatic PDAC will be eligible to enrol. The investigators hypothesize the anticancer activity of low dose OXIRI (LD-OXIRI) regimen comprising of metronomic oxaliplatin (O) and metronomic capecitabine (xeloda; X) in combination with UGT1A1-directed dosing of irinotecan (IRI) to be a tolerable regimen in patients with advanced PDAC and will lead to a favourable response rate. Patients will be prospectively enrolled in two stages - In stage 1, patients will be recruited and evaluated for response and toxicity. In stage 2, more patients will be recruited for further evaluation of response and toxicity.

NCT Number	NCT05929885
Lead Sponsor	National Cancer Centre, Singapore Collaborators: National Medical Research Council (NMRC), Singapore
Conditions	Metastatic Pancreatic Cancer
Enrollment	50 participants
Start Date	2023-08-30
Primary Completion	2027-02-28 (estimated)
Study Completion	2027-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-06-23