Back to resultsTACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial (TACE+RFA)
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Transcatheter arterial chemoembolization
radiofrequency ablation/microwave ablation
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- patients diganosed with hepatocellualr carcinoma beyond Milan criteria
- the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter;
- Child-Pugh A or B
- ECOG score 0-1;
- prothrombin time ≤16 s;
- white cell count ≥3,000/mm3, platelet count ≥40 x 109/L;Hb≥8.5 g/d; ALT/AST≤5×ULN;TB≤3mg/dl;alb≥2.8 g/dl ;Scr ≤2mg/dl
Exclusion Criteria:
- expected survival time < 12 months before random assignment;
- received anticancer surgery or procedure within one month before assignment;
- concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;
- existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;
- upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.
Sites / Locations
- liver cancer institute ,Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TACE group
TACE+RFA/MV group
Arm Description
Transcatheter arterial chemoembolization
Transcatheter arterial chemoembolization and radiofrequency /microwave ablation
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
objective response rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03636620
Brief Title
TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial
Acronym
TACE+RFA
Official Title
Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.
Detailed Description
The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.
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 3
Interventional Study Model
Parallel Assignment
Model Description
TACE vs.TACE+RFA
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TACE group
Arm Type
Active Comparator
Arm Description
Transcatheter arterial chemoembolization
Arm Title
TACE+RFA/MV group
Arm Type
Experimental
Arm Description
Transcatheter arterial chemoembolization and radiofrequency /microwave ablation
Intervention Type
Device
Intervention Name(s)
Transcatheter arterial chemoembolization
Other Intervention Name(s)
TACE
Intervention Description
Transcatheter arterial chemoembolization
Intervention Type
Device
Intervention Name(s)
radiofrequency ablation/microwave ablation
Other Intervention Name(s)
RFA/MW
Intervention Description
radiofrequency ablation/microwave ablation
Primary Outcome Measure Information:
Title
overall survival
Time Frame
up to 46 months
Secondary Outcome Measure Information:
Title
objective response rate
Time Frame
up to 46 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:
patients diganosed with hepatocellualr carcinoma beyond Milan criteria
the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter;
Child-Pugh A or B
ECOG score 0-1;
prothrombin time ≤16 s;
white cell count ≥3,000/mm3, platelet count ≥40 x 109/L;Hb≥8.5 g/d; ALT/AST≤5×ULN;TB≤3mg/dl;alb≥2.8 g/dl ;Scr ≤2mg/dl
Exclusion Criteria:
expected survival time < 12 months before random assignment;
received anticancer surgery or procedure within one month before assignment;
concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;
existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;
upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zheng-gang Ren, doctor
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
liver cancer institute ,Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan to make individual paticipant data available to other researchers
Learn more about this trial
TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial
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