TACE+RFA Versus TACE Alone for Intermediate-stage Hepatocellular Carcinoma

Sponsor
Ming Zhao
Study ID
NCT02435953
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TACE — PROCEDURE
    A catheter (or a microcatheter for cases where small vessels and branches cannot be accessed with a standard angiographic catheter) will be advanced selectively or superselectively into the right or left hepatic artery or the feeding arteries directly supplying the tumor. Depending on tumor size, location, blood supply, and liver function, the interventional radiologist administers a cytotoxic agent and lipiodol emulsion (30 mg lobaplatin, 30 mg pirarubicin, and \< 15 mL lipiodol) through the catheter. Following drug infusion, embolization of the tumor vessels will be routinely performed using gelatin sponge particles.
  • RFA — PROCEDURE
    Commercial electrode systems are used and the ablation therapy is to be performed according to manufacturer's standard recommendations. All lesions are targeted with CT images during the RFA procedure.

Study Details

The current standard treatment for intermediate-stage HCC (BCLC stage B) is transcatheter arterial chemoembolization (TACE) alone. The combination of TACE with RFA has also reported to be an effective treatment for HCC. Some prospective studies have shown that TACE combined with RFA have better efficacy than any of them alone for early stage HCC (single tumor ≤5 cm). However, to the investigators' knowledge, there have not been any prospective studies to assess whether TACE combined sequentially with RFA is more effective than TACE alone for the treatment of intermediate-stage HCC. The investigators hypothesized that the combination of TACE and RFA might result in better patient survival than TACE alone. Thus, the purpose of this study was to prospectively compare the effects of sequential TACE-RFA with TACE alone for the treatment of intermediate-stage HCC. Intermediate-stage HCC in this study was defined as 2-3 intrahepatic lessions, largest tumor size 3-7 cm or 4-10 intrahepatic lessions, largest tumor size ≤7 cm; ECOG-PS 0; Child-pugh A or B7; no tumor thrombus or extrahepatic metastases.

Key Dates

Start date
May 31, 2015
Status verified
Mar 2026
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
241 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TACE-RFA
    RFA follows TACE when achieving ablation eligibility criteria defined in this study, with no more than four sessions of TACE.
  • Active Comparator: TACE alone
    On-demand TACE.

Primary Outcome Measure

Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (PFS-R) [ Time Frame: From the date of randomization to the date of occurrence of radiologic disease progression as determined according to the RECIST v1.1, or death (by any cause), whichever occurs first, assessed up to 10 years. ]

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