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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TACE plus Cyber knife
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring interventional therapy, TACE, Cyberknife

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chinese PLA Gereral Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

combination

Arm Description

TACE plus cyber knife

Outcomes

Primary Outcome Measures

response rate(RR)
CR(complete response)+PR(partial response)
overall survival(OS)
Overall survival was defined as the time from enrollment to death from any cause.

Secondary Outcome Measures

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
Quality of life (QOL)
A questionnaire with questions referred to simple assessments of physical abilities

Full Information

First Posted
August 6, 2017
Last Updated
August 6, 2017
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03243916
Brief Title
Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of MHCC
Official Title
A Prospective Single-arm Study on Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of Massive Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2017 (Anticipated)
Primary Completion Date
July 14, 2019 (Anticipated)
Study Completion Date
July 14, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
interventional therapy, TACE, Cyberknife

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combination
Arm Type
Experimental
Arm Description
TACE plus cyber knife
Intervention Type
Radiation
Intervention Name(s)
TACE plus Cyber knife
Intervention Description
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
Primary Outcome Measure Information:
Title
response rate(RR)
Description
CR(complete response)+PR(partial response)
Time Frame
18 months
Title
overall survival(OS)
Description
Overall survival was defined as the time from enrollment to death from any cause.
Time Frame
26mounth
Secondary Outcome Measure Information:
Title
adverse event(AE)
Description
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
Time Frame
36 month
Title
Quality of life (QOL)
Description
A questionnaire with questions referred to simple assessments of physical abilities
Time Frame
36 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoliang liu, MD
Phone
+86 15801570739
Email
szy957@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Li, MD
Organizational Affiliation
China PLA hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA Gereral Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Li, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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