TORCH

Background

Open-label, phase 3 randomised controlled trial (TORCH, NCT02435953). Two tertiary medical centres in China; enrolment May 2015 – Aug 2024, data cutoff Oct 31, 2025. N=241 intention-to-treat. Barcelona Clinic Liver Cancer (BCLC) stage B hepatocellular carcinoma — liver-confined and not amenable to curative resection or transplant. Median age 59.0 y (TACE-ablation) and 58.0 y (TACE alone); 89.3% and 88.3% male. Baseline 6-and-12 tumour burden score <6 in 28.1% vs 25.8%, 6–12 in 65.3% vs 63.3%, >12 in 6.6% vs 10.8%. Tests whether completing the ablative kill of residual viable tumour after chemoembolization improves outcomes over chemoembolization alone.

Results

Interventions and follow up: Arm A: Transarterial chemoembolization (TACE) followed by subsequent selective radiofrequency ablation (TACE-ablation), n=121
Arm B: TACE alone, n=120
Primary endpoint: Progression-free survival (PFS) per RECIST v1.1
mFollow up: NR; data cutoff Oct 31, 2025 (enrolment opened May 2015).
Results: PFS (primary, RECIST v1.1): 17.7 mo (95% CI 11.4–23.1) vs 7.3 mo (95% CI 6.4–10.4), HR 0.47, 95% CI 0.34–0.65, P<.001.
Untreatable PFS: 35.1 vs 12.3 mo, HR 0.40, 95% CI 0.27–0.58, P<.001.
OS: 88.6 mo (95% CI 43.1–not estimable) vs 35.1 mo (95% CI 25.4–45.5), HR 0.50, 95% CI 0.34–0.73, P<.001.
Subgroups: clinically meaningful PFS and OS gains concentrated in low to moderate tumour burden (6-and-12 score ≤6 and 6–12).
ORR / mRECIST response: NR in the primary report.

Adverse events

Grade 3–4 treatment-related: 23.2% (n=23) with TACE-ablation vs 18.3% (n=24) with TACE alone.
Reported denominators: internally inconsistent with the ITT arm sizes (121 and 120) as published.
Category-level toxicity (hepatic, procedural, haematologic): NR.
Treatment-related deaths: NR.
Discontinuation: NR.

Conclusions

Adding selective thermal ablation after TACE more than doubled median PFS (17.7 vs 7.3 months) and halved the risk of death (HR 0.50) versus TACE alone in liver-confined unresectable HCC, with a comparable grade 3–4 toxicity profile. The 88.6-month median OS in the combination arm is extraordinary for intermediate-stage disease; if reproducible, sequential TACE-ablation becomes a preferred locoregional strategy for ablation-accessible patients with low to moderate tumour burden.

Key Limitations

Two Chinese centres only, in a predominantly HBV-related HCC population — limited generalizability to HCV- and MASLD-driven disease in Western practice. Open-label with investigator-assessed radiological progression, a material bias risk for a PFS primary endpoint; no central imaging review reported. Enrolment spanned 2015–2024, a period in which systemic therapy for unresectable HCC was transformed (atezolizumab–bevacizumab, durvalumab–tremelimumab, TACE-plus-systemic regimens), so the TACE-alone comparator does not reflect contemporary combination standards. Median OS of 88.6 months far exceeds historical BCLC-B benchmarks and the upper confidence bound is not estimable, indicating immature OS data in a highly selected, ablation-accessible population. Reported grade 3–4 AE denominators do not reconcile with the randomised arm sizes.

Clinical Context

TACE is the guideline-standard locoregional therapy for intermediate-stage (BCLC-B) HCC that is not amenable to resection, ablation alone or transplant, per AASLD, EASL and NCCN. The field has been moving toward TACE-plus-systemic combinations following EMERALD-1 (TACE with durvalumab–bevacizumab) and LEAP-012 (TACE with lenvatinib–pembrolizumab), both of which improved PFS over TACE alone. TORCH tests an orthogonal, device-based intensification instead, and is most applicable to patients with limited, ablation-accessible tumour burden. It does not address how sequential TACE-ablation compares with, or should be sequenced against, TACE plus immunotherapy — the head-to-head question that will determine where this fits.

References