Comparison of Efficacy in SBRT of Large HCC With or Without TACE

Study Overview
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Brief Summary
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The study aims to compare efficacy and adverse reactions of large hepatocellular carcinoma participants (5-10cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.

Official Title
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Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Large Hepatocellular Carcinoma (5-10 cm) With or Without Transcatheter Arterial Chemoembolization (TACE)

Conditions
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Large HCC Patients, Stereotactic Body Radiation Therapy, Transcatheter Arterial Chemoembolization

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology single lesion and longest tumor diameter were 5-10cm; CP-A or B classification; Eastern Cooperative Oncology Group (ECOG) score 0-1; distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc. rejecting other therapies such as resection, liver transplantation, etc. platelet count≥50 × 109/L, white blood count≥1.5 × 109/L; patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative. Exclusion Criteria: tumor thrombus; lymph node involvement; extrahepatic metastasis.

Ages Eligible for Study
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Minimum Age: 30 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CK-SBRT with TACE group<br>The hepatocellular carcinoma patients (5-10cm）who received SBRT with TACE. | |
| CK-SBRT group<br>The hepatocellular carcinoma patients (5-10cm）who received SBRT alone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time | OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients. | From date of randomization until the date of death from any cause, assessed up to 36 months | 
| Progression-free survival time | PFS is estimated starting from the date of SBRT to the date of disease progression or patient death. | From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months | 
| Local control time | LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation-induced liver injury rates |  | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. | 
| Adverse reaction |  | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CyberKnife, SBRT, large HCC, prognosis