NCT07501351

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

Efficacy and Safety Comparison Between Intensified Therapy (Plus Lenvatinib) and Conversion Therapy (Regorafenib Combined With PD-(L)1 Inhibitor) For Advanced Hepatocellular Carcinoma After Failure of First-line Bevacizumab Plus Sintilimab: A Prospective, Randomized, Two-Cohort, Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellulcar Carcinoma

Interventions

Type	Name	Description
DRUG	Intensified Therapy	Bevacizumab, 15mg/kg, iv drip, q3w; Sintilimab, 200mg/dose, iv drip, q3w; Lenvatinib, for weight ≤60 kg, 8 mg/d, po, qd; for weight \>60 kg, 12 mg/d, po, qd.
DRUG	Conversion Therapy	Regorafenib, 160mg/d, po, qd; PD-1 inhibitor (Sintilimab, Camrelizumab, Tislelizumab, Toripalimab, Pembrolizumab), 200mg/dose, iv drip, q3w.

Timeline

• Start date: 2026-01-05
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: China