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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Radiation: TACE plus Cyber knife

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Chinese PLA Gereral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combination; TACE plus cyber knife	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Yu Li, MD, China PLA hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2017
• Primary Completion (Anticipated): July 14, 2019
• Study Completion (Anticipated): July 14, 2020

Study Registration Dates

• First Submitted: August 6, 2017
• First Submitted That Met QC Criteria: August 6, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 6, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: TACE; Cyberknife; interventional therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: ChinaPLAGH-MHCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No