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

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Radiation: TACE plus Cyber knife

Study type: Interventional

Funder types: Other

Identifiers

NCT03243916

ChinaPLAGH-MHCC

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

combination

Experimental group

Description:

TACE plus cyber knife

Treatment:

Radiation: TACE plus Cyber knife