PD-1 Plus Lenvatinib vs Regorafenib for Unresectable Hepatocellular Carcinoma
Summary
NIH ClinicalTrials.gov registered a new Phase 2/3 clinical trial (NCT07537985) comparing the efficacy and safety of PD-1 inhibitor combined with Lenvatinib versus PD-1 inhibitor combined with Regorafenib for unresectable hepatocellular carcinoma (UHCC) after failure of first-line treatment with bevacizumab plus sintilimab. The study aims to provide evidence-based guidance for selecting optimal second-line treatment regimens. Estimated enrollment and completion date are listed in the registry.
What changed
This document is a ClinicalTrials.gov study registration entry for NCT07537985, a new clinical trial evaluating PD-1 inhibitor combination therapies for unresectable hepatocellular carcinoma patients who have progressed after first-line bevacizumab plus sintilimab treatment. The trial compares two treatment arms: PD-1 inhibitor with Lenvatinib versus PD-1 inhibitor with Regorafenib, assessing both efficacy and safety as second-line options.
For clinical investigators and healthcare providers, this registry entry indicates an upcoming Phase 2/3 study in the hepatocellular carcinoma treatment landscape. Patients meeting eligibility criteria may benefit from enrollment, and the results may inform future treatment guidelines for second-line therapy selection in advanced liver cancer.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Efficacy and Safety Comparison Between PD-1 Inhibitor Combined With Lenvatinib or With Regorafenib For UHCC After Failure of First-line Treatment
N/A NCT07537985 Kind: NA Apr 17, 2026
Abstract
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.
Conditions: Hepatocellulcar Carcinoma
Interventions: Lenvatinib, Regorafenib, PD-1 Inhibitor
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