Dose-escalation of Regorafenib in Advanced Hepatocellular Carcinoma
Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
The present protocol (STRAT-aHCC trial) aims to prospectively evaluate the tolerability,
quality of life and efficacy of an alternative regimen of regorafenib in patients with
advanced hepatocellular carcinoma (HCC) after progression to first-line. Patients will
receive increasing dose of regorafenib in the first 2 treatment cycles (initial dose of 80mg,
with weekly increments of 40mg up to 160mg in the first 2 treatment cycles). From the 3rd
cycle on, the maximum tolerated dose during the first 2 cycles will be maintained. The
maximum tolerated dose will be considered the highest dose in which the patient does not
present grade ≥3 adverse events. The primary endpoint is the proportion of evaluable patients
completing cycle 4. Radiologic response rate, quality of life, time to progression and
overall survival will be evaluated as secondary endpoints.