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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2022-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

group 1 RFA alone group 2 TACE alone
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RFA group

Patients in RFA group will accept RFA treatment

Group Type EXPERIMENTAL

radiotherapy ablation

Intervention Type DEVICE

We using Cool Tip system or RITA system to perform RFA

TACE group

Patients in TACE group will accept TACE treatment

Group Type ACTIVE_COMPARATOR

transarterial chemoembolization(TACE)

Intervention Type DEVICE

TACE treatment is a first line treatment for BCLC stage B HCC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

radiotherapy ablation

We using Cool Tip system or RITA system to perform RFA

Intervention Type DEVICE

transarterial chemoembolization(TACE)

TACE treatment is a first line treatment for BCLC stage B HCC

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zheng-Gang Ren

zhongshan hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhenggang Ren, doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongshan hospital Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xin Yin, doctor

Role: CONTACT

+86-21-64041990

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xin Yin, doctor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LC-RFA vs.TACE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.