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Phase II Study of Moderate-dose Hypofractionated Radiotherapy Combined With Tislelizumab for Hepatocellular Carcinoma With Diffuse Tumor Thrombosis Involved Both Left and Right Liver
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.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College
Beijing, China
Start Date
January 25, 2024
Primary Completion Date
January 1, 2026
Completion Date
January 1, 2026
Last Updated
January 31, 2024
30
ESTIMATED participants
Moderate-dose Hypofractionated Intensity-modulated Radiotherapy
RADIATION
Tislelizumab
DRUG
Lead Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
NCT06811116
NCT07485114
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