NCT06040177

Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus#a Prospective, Multicenter, Single-arm Clinical Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: First Affiliated Hospital of Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of SBRT combined with cardonilizumab and lenvastinib in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus

Conditions

• Hepatocellular Carcinoma Non-resectable
• Portal Vein Tumor Thrombus
• Immune Checkpoint Inhibitors

Interventions

Type	Name	Description
DRUG	Cadonilimab	Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years
RADIATION	Stereotactic radiotherapy	Radiation therapy: Stereotactic radiotherapy (5-8Gy\*5F) for portal vein thrombus within 21 days after entry
DRUG	Renvatinib	Renvatinib: 8mg (weight \<60kg) or 12mg (weight 60kg) once a day until disease progression, intolerable toxicity

Timeline

• Start date: 2023-02-02
• Primary completion: 2023-02-02
• Completion: 2025-02-01
• First posted: 2023-09-15
• Last updated: 2023-09-15

Locations

1 site across 1 country: China