Lenvatinib Plus VIC-1911 in Lenvatinib-unresponsive or Lenvatinib-resistant HCC

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Liver CancerHepatocellular CarcinomaResistant Cancer
Interventions
DRUG

Lenvatinib Oral Product Plus VIC1911

"Lenvatinib: 8mg/day (≤ 60Kg), oral. VIC-1911:Groups were divided: 100mg bid(DL1, dose level 1); 150mg bid(DL2); 200mg bid(DL3), oral. 50mg bid is defined as DL(-1), 250mg bid is defined as DL(+1). A Bayesian Optimal Interval design schema will be followed to establish the maximum tolerated dose (MTD) of lenvatinib plus VIC-1911 combination and RP2D of VIC-1911 in HCC patients. The study would follow the Bayesian Optimal Interval Design with level size of 2 patients. The R package BOIN is available from CRAN."

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