A Phase 3 trial investigating TACE+RFA versus TACE alone for intermediate-stage hepatocellular carcinoma reached primary completion on 2025-10-31, enrolling 241 participants.
Background
Hepatocellular carcinoma (HCC) is a significant global health concern. For intermediate-stage HCC (BCLC stage B), transcatheter arterial chemoembolization (TACE) alone is the current standard treatment. The combination of TACE with radiofrequency ablation (RFA) has been explored as an effective treatment for HCC, with some prospective studies suggesting better efficacy for early-stage HCC (single tumor ≤5 cm) when TACE is combined with RFA. However, there has been a lack of prospective studies to assess whether TACE combined sequentially with RFA offers superior efficacy compared to TACE alone for intermediate-stage HCC.
Trial design
This Phase 3 study enrolled 241 participants to compare two treatment approaches for intermediate-stage hepatocellular carcinoma. The trial investigated Hepatocellular Carcinoma, specifically looking at Chemoembolization, Therapeutic (TACE) and Ablation Techniques, RFA. The study compared the efficacy of TACE combined sequentially with RFA against TACE alone.
What this means
The primary completion of this Phase 3 trial marks a significant step towards understanding the potential benefits of combining TACE with RFA for intermediate-stage liver cancer. While specific results are not yet available, the completion of data collection for 241 participants suggests that comprehensive data will soon be analyzed. The findings from this study could potentially influence future treatment guidelines for hepatocellular carcinoma, offering clinicians and patients more evidence-based options beyond TACE alone if the combination therapy proves more effective.
Source
The information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public registry of clinical studies. The update for study NCT02435953, titled 'TACE+RFA Versus TACE Alone for Intermediate-stage Hepatocellular Carcinoma', was posted on 2025-10-31 on clinicaltrials.gov.
