Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of MHCC

Study Overview
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Brief Summary
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Hepatocellular carcinoma is a highly malignant tumor that is progressing rapidly. Hepatic arterial embolization chemotherapy (TACE) is a common method for the treatment of unresectable of hepatocellular carcinoma.But for patients with > 10cm hepatocellular carcinoma, the intervention effect was not satisfied.The cyberknife is a kind of stereotactic radiotherapy which can track the movement of tumor and monitor the position deviation of tumor in real time.This stuy is aimed to observe the efficiency and safety of the combination of TACE and cyberknife in the treatment of massive hepatocellular carcinoma.

Official Title
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A Prospective Single-arm Study on Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of Massive Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: TACE plus Cyber knife


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed hepatocellular carcinoma No lymph node metastasis or distant metastasis Tumor diameter at least 10 cm Hepatic lesions are not suitable for surgical resection or the patient refuse to surgical treatment Eastern Clinical Oncology Group (ECOG)score is 0， 1or2 No history of abdominal radiotherapy Inoperable and untransplantable,Child-pugh score A or B Normal liver volume exceeds 700 cm3 Exclusion Criteria: Previous history of abdominal radiotherapy; The maximum diameter of tumor is less than 10cm; The liver Child is graded C; Contraindication for radiotherapy; Active gastrointestinal bleeding occurred within 2 weeks before enrollment Pregnancy Undergoing chemotherapy throughout the past six months Diffuse hepatocellular carcinoma Main portal vein tumor embolization Undergoing other simultaneous treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combination<br>TACE plus cyber knife | Radiation: TACE plus Cyber knife<br>* Patients with histologically confirmed MHCC(Massive Hepatocellular Carcinoma) will receive TACE therapy,after 1 or 2 week's recovery from hepatic insufficiency ,the targeted and staged cyber knife will be given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate(RR) | CR(complete response)+PR(partial response) | 18 months | 
| overall survival(OS) | Overall survival was defined as the time from enrollment to death from any cause. | 26mounth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event(AE) | Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause | 36 month | 
| Quality of life (QOL) | A questionnaire with questions referred to simple assessments of physical abilities | 36 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TACE, interventional therapy, Cyberknife