SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    170
  • sponsor
    Sun Yat-sen University
Updated on 19 February 2024
carcinoma
radiofrequency ablation
hepatocellular carcinoma
stereotactic body radiation therapy
recurrent hepatocellular carcinoma

Summary

This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of SBRT for perivascular hepatocellular carcinoma, compared with RFA.

Description

The primary endpoint is 1-year local recurrence rate and disease-free survival. We planned to recruit 170 patients who diagnosed as perivascular hepatocellular carcinoma. The patients will be randomized into SBRT group and RFA group as 1:1 ratio.

Details
Condition Adenocarcinoma, Adenocarcinoma, HEPATIC NEOPLASM, liver cancer, HEPATOCELLULAR CARCINOMA, liver cancer
Age 18years - 75years
Treatment Stereotactic Body Radiation Therapy, Radiofrequency ablation
Clinical Study IdentifierNCT04434989
SponsorSun Yat-sen University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma after curative treatment
Unifocal tumor 5cm
Closed to great vessels (diameter 3mm)
ECOG score 0-1
Child-Pugh grade A or B7
Sufficient liver and kidney function

Exclusion Criteria

Vascular invasion
Extra-hepatic metastasis
Received TACE before
Inflammation of local skin
Dysfunction of liver, kidney or bone marrow
Concomitant other malignant tumor or HIV infection
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