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Fostrox + Lenvatinib vs. Lenvatinib in Advanced HCC
NCT07493668Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2026
- Primary completion
- Apr 2028
- Countries
- 1
- Sponsor
- CHA University
- Modality
- Metabolically Activated Prodrugs
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, randomised, open-label trial of Fostroxacitabine bralpamide in hepatocellular carcinoma (HCC) (2 arms), sponsored by CHA University. Primary endpoint: Objective Response Rate by Independent Review Facility According to RECIST v1.1. Started May 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Fostrox + Lenvatinib
Fostrox orally once daily on Days 1-5 of each 21-day cycle + continuous daily lenvatinib
Lenvatinib
Continuous daily lenvatinib alone
03
Who it enrols
Adults with locally advanced or unresectable metastatic HCC who progressed on first-line IO combination therapy, with Child-Pugh A liver function and ECOG PS 0-1.
04
Endpoints
Primary
Objective Response Rate by Independent Review Facility According to RECIST v1.1
Secondary
Objective Response Rate by Investigator According to RECIST v1.1
Objective Response Rate by Investigator According to mRECIST
Duration of Response by Investigator According to RECIST v1.1
Duration of Response by Investigator According to mRECIST
Disease Control Rate by Investigator According to RECIST v1.1
Disease Control Rate by Investigator According to mRECIST
Progression-Free Survival by Investigator According to RECIST v1.1
Progression-Free Survival by Investigator According to mRECIST
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