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NOT YET RECRUITING
NCT07099794
PHASE2

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

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.

Official title: Liposomal Irinotecan (II) and Fluorouracil and Calcium Folinate in Combination With or Without Renvastinib for Second-line Treatment of Advanced Biliary System Tumors: a Randomized, Two-cohort, Prospective Phase II Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-08-01

Completion Date

2029-08-31

Last Updated

2025-08-01

Healthy Volunteers

No

Interventions

DRUG

Liposomal irinotecan+5-FU/LV+Lenvatinib

Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w Renvastinib: ≥60kg, 12mg; \<60kg, 8mg, PO, once daily 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w

DRUG

NALIRI

Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w

Locations (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China