NCT07099794View on ClinicalTrials.gov

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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

February 28, 2029

Study Completion Date

August 31, 2029

Conditions
Biliary Tract Cancer (BTC)
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

Trial Locations (1)

Unknown

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

All Listed Sponsors
lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER