Back to resultsEvaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
radiotherapy ablation
transarterial chemoembolization(TACE)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion criteria:
- age 18 to 75 years ;
- HCC confirmed by pathological or clinical diagnosis according to the American Association for the Study of Liver Diseases criteria ;
- solitary HCC less than 7cm in diameter or multiple HCC lesions less 5
- the absence of portal/hepatic vein invasion, lymph node involvement and extrahepatic metastases;
- lesions visible on ultrasound with a safe path between the lesion and skin;
- an Eastern Cooperative Oncology Group performance status of 0-1;
- Child-Pugh class A or B cirrhosis.
The exclusion criteria :
- received any other previous treatment for HCC;
- severe coagulation disorders;
- evidence of hepatic decompensation including hepatic encephalopathy, ascites as well as esophageal or gastric variceal bleeding;
- presence of serious medical comorbidities, including serious dysfunction of the heart or kidney ;
- currently had other malignancies in addition to HCC.
Sites / Locations
- Zhongshan hospital Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RFA group
TACE group
Arm Description
Patients in RFA group will accept RFA treatment
Patients in TACE group will accept TACE treatment
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
objective response rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03642561
Brief Title
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
Official Title
Liver Cancer Institiute ,Fudan University
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
Detailed Description
The investigators conduct this clinical trial to evaluate the treatment outcome of RFA in HCC patients with tumor smaller than 7cm and tumor number less than five ,in comparison with TACE treatment.The primary outcome is overall survival.The secondary outcome is objective response rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
group 1 RFA alone group 2 TACE alone
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RFA group
Arm Type
Experimental
Arm Description
Patients in RFA group will accept RFA treatment
Arm Title
TACE group
Arm Type
Active Comparator
Arm Description
Patients in TACE group will accept TACE treatment
Intervention Type
Device
Intervention Name(s)
radiotherapy ablation
Intervention Description
We using Cool Tip system or RITA system to perform RFA
Intervention Type
Device
Intervention Name(s)
transarterial chemoembolization(TACE)
Intervention Description
TACE treatment is a first line treatment for BCLC stage B HCC
Primary Outcome Measure Information:
Title
overall survival
Time Frame
up to 60 months
Secondary Outcome Measure Information:
Title
objective response rate
Time Frame
up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
age 18 to 75 years ;
HCC confirmed by pathological or clinical diagnosis according to the American Association for the Study of Liver Diseases criteria ;
solitary HCC less than 7cm in diameter or multiple HCC lesions less 5
the absence of portal/hepatic vein invasion, lymph node involvement and extrahepatic metastases;
lesions visible on ultrasound with a safe path between the lesion and skin;
an Eastern Cooperative Oncology Group performance status of 0-1;
Child-Pugh class A or B cirrhosis.
The exclusion criteria :
received any other previous treatment for HCC;
severe coagulation disorders;
evidence of hepatic decompensation including hepatic encephalopathy, ascites as well as esophageal or gastric variceal bleeding;
presence of serious medical comorbidities, including serious dysfunction of the heart or kidney ;
currently had other malignancies in addition to HCC.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Yin, doctor
Phone
+86-21-64041990
Email
yin.xin@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenggang Ren, doctor
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan hospital Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Yin, doctor
Email
yin.xin@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
zhenggang Ren, professor
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make IPDavailable to other researchers
Learn more about this trial
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
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