Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
Liver Cancer Institiute ,Fudan University
1 other identifier
interventional
300
1 country
1
Brief Summary
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedStudy Start
First participant enrolled
September 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJuly 28, 2020
July 1, 2020
2.9 years
August 8, 2018
July 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
overall survival
up to 60 months
Secondary Outcomes (1)
objective response rate
up to 60 months
Study Arms (2)
RFA group
EXPERIMENTALPatients in RFA group will accept RFA treatment
TACE group
ACTIVE COMPARATORPatients in TACE group will accept TACE treatment
Interventions
TACE treatment is a first line treatment for BCLC stage B HCC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Zhongshan hospital Fudan University
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhenggang Ren, doctor
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- zhongshan hospital
Study Record Dates
First Submitted
August 8, 2018
First Posted
August 22, 2018
Study Start
September 3, 2019
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
July 28, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share
No plan to make IPDavailable to other researchers