Efficacy and Safety Comparison Between PD-1 Inhibitor Combined With Lenvatinib or With Regorafenib For UHCC After Failure of First-line Treatment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |