CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis

Study Overview
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Brief Summary
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The aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cirrhosis.

Official Title
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CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: Cyberknife stereotactic body radiation therapy


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 Unfeasible or refusing to undergo other treatments; Residual normal liver volume ≥700 cc; With decompensated cirrhosis (Child-Pugh B or C classification); Without portal vein tumor thrombus; Eastern Cooperative Oncology Group (ECOG) score 0-1; Distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm； 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: With Tumor thrombus； With extrahepatic metastasis; With lymph node involvement.

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

| Intervention/Treatment |
| --- |
|Radiation: Cyberknife stereotactic body radiation therapy|A total dose of 45-54 Gy in 5-10 fractions was given according to the location of lesions for small HCC patients with decompensated cirrhosis.|

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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hepatocellular carcinoma, CyberKnife, stereotactic body radiation therapy, Child-Pugh B classification, Child-Pugh C classification