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Lenvatinib

Tislelizumab

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Antineoplastic Agents, Immunological

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 concurrent with Tislelizumab, followed Tislelizumab±lenvatinib for maintenance.

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.

Moderate-dose Hypofractionated Intensity-modulated Radiotherapy

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.

Bo Chen, MD

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.

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

Median Overall Survival (mOS) is defined as the median of Overall Survival (OS). OS is defined as the time from the end of radiotherapy to death from any cause

Treatment response was defined as the best response in 3 months after radiotherapy. ORR is defined as the percentage of patients who met the complete response (CR) or partial response (PR) criteria as defined by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST 1.1

Progression-free Survival (PFS) is defined as the time from the end of RT until tumor progression or death from any cause.

Toxicity is assessed and graded according to the Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Professor

Pembrolizumab

Immune Checkpoint Inhibitors

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 concurrent with Pembrolizumab, followed Pembrolizumab±lenvatinib for maintenance.

One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab 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 Pembrolizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance.

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 Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab 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 Pembrolizumab 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.

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

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

Toxicity is assessed and graded according to the Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).

Toxicity is assessed and graded according to the Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).

Toxicity is assessed and graded according to the Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).

Toxicity is assessed and graded according to the Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis	NCT06233981	Hepatocellular ... Radiotherapy Tislelizumab Tumor Thrombosi...	Moderate-dose H... Tislelizumab	18 Years - 90 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis	NCT06389422	Hepatocellular ... Radiotherapy Pembrolizumab Tumor Thrombosi...	Moderate-dose H... Pembrolizumab	18 Years - 90 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis	NCT06389422	Hepatocellular ... Radiotherapy Pembrolizumab Tumor Thrombosi...	Moderate-dose H... Pembrolizumab	18 Years - 90 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis	NCT06389422	Hepatocellular ... Radiotherapy Pembrolizumab Tumor Thrombosi...	Moderate-dose H... Pembrolizumab	18 Years - 90 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis	NCT06233981	Hepatocellular ... Radiotherapy Tislelizumab Tumor Thrombosi...	Moderate-dose H... Tislelizumab	18 Years - 90 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Spots Global Cancer Trial Database for tumor thrombosis