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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03243916
• Other study ID #: ChinaPLAGH-MHCC
• Status: Not yet recruiting
• Phase: N/A
• First received: August 6, 2017
• Last updated: August 6, 2017
• Start date: August 15, 2017
• Est. completion date: July 14, 2020

Study information

• Verified date: August 2017
• Source: Chinese PLA General Hospital
• Contact: Xiaoliang liu, MD
• Phone: +86 15801570739
• Email: szy957[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 14, 2020
• Est. primary completion date: July 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• TACE plus Cyber knife
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

Locations

Country	Name	City	State
China	Chinese PLA Gereral Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate(RR)	CR(complete response)+PR(partial response)	18 months
Primary	overall survival(OS)	Overall survival was defined as the time from enrollment to death from any cause.	26mounth
Secondary	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
Secondary	Quality of life (QOL)	A questionnaire with questions referred to simple assessments of physical abilities	36 month