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

August 6, 2017 updated by: YuLi, Chinese PLA General Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 18 months
CR(complete response)+PR(partial response)
18 months
overall survival(OS)
Time Frame: 26mounth
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)
Time Frame: 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
36 month
Quality of life (QOL)
Time Frame: 36 month
A questionnaire with questions referred to simple assessments of physical abilities
36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Yu Li, MD, China PLA hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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