A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen

This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.

NCT Number	NCT07099794
Lead Sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions	Biliary Tract Cancer (BTC)
Enrollment	90 participants
Start Date	2025-08-01
Primary Completion	2029-02-28 (estimated)
Study Completion	2029-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-01