drugset / Trial / NCT07501351

Efficacy and Safety Comparison Between Intensified Therapy and Conversion Therapy For Advanced HCC After Failure of First-line

NCT07501351

Phase 2 Recruiting 80 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

Although immunotherapy-based therapies (including targeted-immunotherapy or dual-immunotherapy protocols) have become the first-line standard treatment for advanced hepatocellular carcinoma (HCC), there remains a lack of high-level evidence to guide the selection of second-line therapies following progression in immune checkpoint inhibitors (ICIs). Additionally, direct comparative data are scarce for combination treatment modalities such as "continuation of the original first-line regimen with added agents" or "switching to agents with different mechanisms". To address this clinical need and explore novel second-line treatment strategies for advanced HCC, we plan to conduct an exploratory clinical trial to investigate the efficacy and safety comparison between intensified therapy (plus lenvatinib) and conversion therapy (regorafenib combined with PD-1 inhibitor) for advanced hepatocellular carcinoma after failure of fFirst-line bevacizumab plus sintilimab.

Timeline

Start
2026-01-05
Primary completion
2026-10-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Regorafenib Small molecule 160 mg Oral
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Subject Toripalimab Monoclonal antibody 200 mg Intravenous