drugset / Trial / NCT07537985

Efficacy and Safety Comparison Between PD-1 Inhibitor Combined With Lenvatinib or With Regorafenib For UHCC After Failure of First-line Treatment

NCT07537985

Completed 200 enrolled Sun Yat-sen University
NaParallel-groupOpen-labelTreatment

Summary

There is no definitive evidence regarding the therapeutic efficacy of PD-1 inhibitors combined with tyrosine kinase inhibitors (TKIs) after disease progression following first-line treatment with bevacizumab plus sintilimab for unresectable hepatocellular carcinoma (HCC). There is insufficient evidence to support which TKI should be combined with PD-1 inhibitors as the optimal second-line treatment option after first-line therapy failure. Data on the application of lenvatinib as a second-line treatment are limited, whereas the efficacy and safety of regorafenib combined with PD-1 inhibitors have been preliminarily validated \[9\]. Therefore, this study aims to compare the efficacy and safety of PD-1 inhibitors combined with either lenvatinib or regorafenib after disease progression following first-line bevacizumab plus sintilimab treatment for unresectable HCC, providing evidence-based guidance for the selection of second-line treatment regimens in clinical practice.

Timeline

Start
2020-01-01
Primary completion
2025-08-01
Completion
2025-12-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Comparator Regorafenib Small molecule 160 mg Oral
Background Camrelizumab Monoclonal antibody 200 mg Intravenous
Background Nivolumab Monoclonal antibody 200 mg Intravenous
Background Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background Sintilimab Monoclonal antibody 200 mg Intravenous
Background Tislelizumab Monoclonal antibody 200 mg Intravenous
Background Toripalimab Monoclonal antibody 200 mg Intravenous