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Ongoing important trials

LEAP-012 — pembrolizumab + lenvatinib + TACE in intermediate HCC

Pembrolizumab Plus Lenvatinib Plus TACE Versus TACE in Intermediate-Stage HCC (LEAP-012)

Phase
Phase III
Recruitment
Terminated
Results maturity
Interim analysis
Publication
Peer-reviewed
Regulatory approval
No regulatory approval
NCT
NCT04246177
Registry checked
2026-10-29
Editorial update
2026-10-29

Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.

For patients

What is being studied? Adding immunotherapy and a targeted drug to local liver treatment is being studied.

What did it show? Randomized evaluation of adding systemic IO+TKI to locoregional therapy; PFS improved, no OS claim.

What is not proven? Transfer to early/advanced HCC; net benefit without toxicity.

Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.

For clinicians

Lancet 2025 LEAP-012: median PFS 14.6 vs 10.0 mo. Terminated on CT.gov; PFS ≠ OS. Cross-read with HCC Landmark.

Cancer / population: Liver (HCC) — Ara evre HCC (TACE adayı)

Intervention: Pembrolizumab + lenvatinib + TACE

Primary endpoint: PFS / OS (protokol)

Source-verified summary: PFS 14,6 vs 10,0 ay (Lancet 2025). OS üstünlüğü bu karttan iddia edilmez; çalışma sonlandırıldı.

Limitations: Ara evre seçimi kritik; toksisite yönetimi; OS iddiası yok.

Sources

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