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SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

Recruiting
18-75 years
All
Phase N/A

Overview

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  1. Vascular invasion
  2. Extra-hepatic metastasis
  3. Received TACE before
  4. Inflammation of local skin
  5. Dysfunction of liver, kidney or bone marrow.
  6. Concomitant other malignant tumor or HIV infection

Study details
    Adenocarcinoma
    Adenocarcinoma
    HEPATIC NEOPLASM
    liver cancer
    HEPATOCELLULAR CARCINOMA
    liver cancer

NCT04434989

Sun Yat-sen University

16 February 2024

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