15
Participants
Start Date
August 1, 2024
Primary Completion Date
July 31, 2025
Study Completion Date
July 31, 2026
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."
RECRUITING
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai
RenJi Hospital
OTHER