Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC

NARecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

July 31, 2025

Study Completion Date

July 31, 2026

Conditions
Hepatocellular Carcinoma
Interventions
DRUG

Lenvatinib Combined with VIC-1911

"Oral administration:~Lenvatinib:~Take the clinically normal dose: ≤60Kg body weight, 8mg/day; \>60Kg body weight, 12mg/day;~VIC-1911:~Phase 1: Accelerated titration phase Plan to enroll 3 patients. First, enroll 1 patient, give the initial dose of VIC-1911 25mg BID, observe for 1 week, if there is no dose-limiting toxicity (DLT), increase to 50mg BID. At the same time, enroll another 2 patients, give VIC-1911 25mg BID, observe for 1 week, if no DLT, increase to 50mg BID. Observe for 2 weeks at a dose of 50mg, if no DLT occurs, continue to increase to 75mg BID, observe for 4 weeks. If no DLT occurs, continue to increase by 25mg doses, with an observation period of 4 weeks, until one case of dose-limiting toxicity or two cases of moderate toxicity occur during the titration process, then reduce to the previous dose, and determine it as the final dosing regimen.~Phase 2: Expansion phase According to the final dosing regimen selected, enroll 12 patients and observe for 3 months."

Trial Locations (1)

200127

RECRUITING

Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai

All Listed Sponsors
lead

RenJi Hospital

OTHER