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

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: TACE plus Cyber knife

• Registration Number: NCT03243916
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-06
• Study First Submitted QC: 2017-08-06
• Last Update Submitted: 2017-08-06
• Study First Posted: 2017-08-09
• Last Update Posted: 2017-08-09
• Study Start: 2017-08-15
• Primary Completion: 2019-07-14
• Study Completion: 2020-07-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
combination	TACE plus Cyber knife	TACE plus cyber knife

Primary Outcome Measures

Name	Time	Method
overall survival(OS)	26mounth	Overall survival was defined as the time from enrollment to death from any cause.
response rate(RR)	18 months	CR(complete response)+PR(partial response)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chinese PLA Gereral Hospital; 🇨🇳 Beijing, Beijing, China