NCT06233981

Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis

Phase II Study of Moderate-dose Hypofractionated Radiotherapy Combined With Tislelizumab for Hepatocellular Carcinoma With Diffuse Tumor Thrombosis Involved Both Left and Right Liver

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Tislelizumab at a dose of 200mg. Subsequently, Tislelizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Tislelizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.

Conditions

• Hepatocellular Carcinoma
• Radiotherapy
• Tislelizumab
• Tumor Thrombosis

Interventions

Type	Name	Description
RADIATION	Moderate-dose Hypofractionated Intensity-modulated Radiotherapy	All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center.
DRUG	Tislelizumab	One week before or during the radiotherapy, patients receive concurrent Tislelizumab at a dose of 200mg. Subsequently, Tislelizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Tislelizumab, which may be escalated up to a maximum of 12 mg per day, until disease progression or intolerance or death.

Timeline

• Start date: 2024-01-25
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-01-31
• Last updated: 2026-04-17

Locations

1 site across 1 country: China