Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis

Study Overview
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Brief Summary
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Macrovascular invasion (MVI) is common in HCC, Portal vein tumor thrombus (PVTT) is the most common form of MVI in HCC, with an incidence ranging from 44 to 62.2%. About 10% to 60% of HCC patients have PVTT at the time of diagnosis. the prognosis for those with PVTT remains poor, as their median survival is only 2-4 months via supportive care. There is currently no widely-accepted consensus for the management of HCC with PVTT. According to some guidelines in Europe and America, HCC with PVTT is regarded as Stage C per Barcelona Clinic Liver Cancer (BCLC) Staging system, and sorafenib alone is recommended as the treatment of choice. This study is to analyze the safety and efficacy of radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis.

Official Title
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Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis

Conditions
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Hepatocellular Carcinoma Non-resectable, Portal Vein Tumor Thrombosis, Stereotactic Body Radiotherapy

Intervention / Treatment
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* Radiation: stereotactic body raiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: tumor thrombus involving the main trunk and/or first branches of the portal vein, unsuitable for surgery or TACE; an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2; 3. no refractory ascites; 4. Child-Pugh class A and B, or class C with good performance status; 5. no previous radiotherapy to the liver; 6. more than 700 cc of uninvolved liver Exclusion Criteria: Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.; Diffuse HCC or accompanied by distant metastasis; Severe bleeding tendency or coagulation dysfunction within the previous 6 months; Patients with a history of hepatic encephalopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: radiotherapy<br>stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis | Radiation: stereotactic body raiotherapy<br>* stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | The time from the patient received treatment to died from any cause | from enrollment to death (for any reason).assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | complete or partial response after treatment | from enrollment to progression or death (for any reason),assessed up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, Portal vein tumor thrombosis, Stereotactic body radiotherapy