Trial reportCardiovascular and interventional radiology2022
Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment.
Trial report in Cardiovascular and interventional radiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04246177 (A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib), which is not on this map. Cited by 88 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
Who cites it
88 citing papers in PubMed, 3 syntheses or guidelines pooled it, 101 citations in OpenAlex.
- Locoregional Therapies for Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis.JAMA network open · 2024Pooled it
- Phase I-IV Drug Trials on Hepatocellular Carcinoma in Asian Populations: A Systematic Review of Ten Years of Studies.International journal of molecular sciences · 2024Pooled it
- TACE plus tyrosine kinase inhibitors and immune checkpoint inhibitors versus TACE plus tyrosine kinase inhibitors for the treatment of patients with hepatocellular carcinoma: a meta-analysis and trial sequential analysis.Hepatology international · 2024Pooled it
- Anticancer effects of vitamin K combined with transarterial chemoembolization in hepatocellular carcinoma, a randomized controlled trial.British journal of cancer · 2025Trial
- KLF16 promotes immune escape in hepatocellular carcinoma cells by upregulating PD-L1 expression via PRKDC.Translational oncology · 2026Article
- Transarterial chemoembolization combined with tyrosine kinase inhibitors and programmed death-1 inhibitors in recurrent intermediate and advanced hepatocellular carcinoma: a single-centre retrospective cohort study.BMC gastroenterology · 2026Article
- Prognostic Value of Skeletal Muscle Loss in Unresectable Hepatocellular Carcinoma Treated with TACE-Based Combination Therapy.Journal of clinical medicine · 2026Article
- Double spring coil transarterial chemoembolization approach integrating with sorafenib for hepatocellular carcinoma patients with portal vein tumor thrombus: A retrospective cohort study.Chinese medical journal · 2026Article
- TACE plus donafenib and immune checkpoint inhibitors for intermediate HCC (CHANCE2410 study): a propensity score matching analysis.European radiology experimental · 2026Article
- Sequential Use of Systemic Therapy With Locoregional Therapy for Hepatocellular Carcinoma in Japan: Analyses of Real-World Data Based on a Health Claims Database.Cancer medicine · 2026Article
- Safety of Immune Checkpoint Inhibitors Prior to Liver Transplantation in Hepatocellular Carcinoma.Alimentary pharmacology & therapeutics · 2026Article
- Article
- Evaluating the Efficacy and Safety of TACE Combined with Iodine-125 Brachytherapy Versus TACE Monotherapy for Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2026Review
- The State of the Art in Combination Locoregional and Systemic Treatment Strategies for Hepatocellular Carcinoma: Recent Advancements and Future Horizons.Current oncology (Toronto, Ont.) · 2026Review
- Synergistic Anticancer Effects of Lenvatinib Combined with N-butylidenephthalide in Human Colorectal Cancer Cells.International journal of medical sciences · 2026Article
- Combination of locoregional and systemic therapy for hepatocellular carcinoma with portal vein tumor thrombus: a real-world retrospective study.Frontiers in oncology · 2026Article
- Stage-Dependent Efficacy of TACE Combined with Tyrosine Kinase and Immune Checkpoint Inhibitors as Conversion Therapy for Unresectable Hepatocellular Carcinoma: A Multicenter Retrospective Study.Journal of hepatocellular carcinoma · 2026Article
- Advances in transarterial chemoembolization for hepatocellular carcinoma: Integration with systemic therapies and emerging treatment strategies.Cancer pathogenesis and therapy · 2026Review
- Integrating Combination Therapy and Smart Embolic Materials to Overcome the Therapeutic Ceiling of Transarterial Chemoembolization in Hepatocellular Carcinoma.Journal of hepatocellular carcinoma · 2026Review
- TKI plus ICI versus ICI alone in high tumor burden hepatocellular carcinoma: a retrospective cohort study.Journal of cancer research and clinical oncology · 2025Article
28 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 9 institutions in 5 countries.
Funding
Abstract
purposeTransarterial chemoembolization (TACE) is the standard of care for patients with intermediate-stage hepatocellular carcinoma (HCC). Lenvatinib, a multikinase inhibitor, and pembrolizumab, a PD-1 inhibitor, have shown efficacy and tolerability in patients with HCC, and adding this combination to TACE may enhance clinical benefit. PROTOCOL: LEAP-012 is a prospective, double-blind randomized phase 3 study. Adults with confirmed HCC localized to the liver without portal vein thrombosis and not amenable to curative treatment, ≥ 1 measurable tumor per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), Eastern Cooperative Oncology Group performance status 0 or 1, Child-Pugh class A and no previous systemic treatment for HCC are eligible. Patients will be randomly assigned to lenvatinib once daily plus pembrolizumab every 6 weeks plus TACE or placebos plus TACE. Dual primary endpoints are overall survival and progression-free survival per RECIST 1.1 by blinded independent central review (BICR). Secondary endpoints are progression-free survival, objective response rate, disease control rate, duration of response and time to progression per modified RECIST by BICR; objective response rate, disease control rate, duration of response and time to progression per RECIST 1.1 by BICR; and safety. STATISTICS: The planned sample size, 950 patients, was calculated to permit accumulation of sufficient overall survival events in 5 years to achieve 90% power for the overall survival primary endpoint. DISCUSSION: LEAP-012 will evaluate the clinical benefit of adding lenvatinib plus pembrolizumab to TACE in patients with intermediate-stage HCC not amenable to curative treatment. CLINICALTRIALS: gov NCT04246177.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.