Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
NCT ID: NCT03642561
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2019-09-03
2022-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RFA group
Patients in RFA group will accept RFA treatment
radiotherapy ablation
We using Cool Tip system or RITA system to perform RFA
TACE group
Patients in TACE group will accept TACE treatment
transarterial chemoembolization(TACE)
TACE treatment is a first line treatment for BCLC stage B HCC
Interventions
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radiotherapy ablation
We using Cool Tip system or RITA system to perform RFA
transarterial chemoembolization(TACE)
TACE treatment is a first line treatment for BCLC stage B HCC
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zheng-Gang Ren
zhongshan hospital
Principal Investigators
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Zhenggang Ren, doctor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan hospital Fudan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LC-RFA vs.TACE
Identifier Type: -
Identifier Source: org_study_id
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