Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
NCT06040177 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-09-15
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
- 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
Sponsors & Collaborators
-
First Affiliated Hospital of Guangxi Medical University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-02
- Primary Completion
- 2023-02-02
- Completion
- 2025-02-01
Countries
- China
Study Locations
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