Carcinoma, Hepatocellular
Recent clinical, regulatory, research and industry developments relating to this disease.
Metabolic Dysfunction-Associated Steatotic Liver Disease in Adults: A Review.
Hepatocellular carcinoma: signaling pathways and therapeutic advances.
An Update of AI and Radiomics in Precision Oncology: Insights from Liver Tumors as Case Models.
Interventional Oncology Meets Immuno-oncology: Combination Therapies for Hepatocellular Carcinoma.
Epidemiology of metabolic dysfunction-associated steatotic liver disease.
Approval: Sorafenib Accord (EMA)
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 2 clinical trials expected to report results, the earliest in Q2 2027.
- Active recent publication activity, including 1 notable finding.
Research HighlightsViewHide
Clinical MilestonesViewHide
- 2026-06-18A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or AblationResults posted
- 2026-02-05A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)Results posted
- 2025-09-30A Phase III Randomized Double-blind Study of Pembrolizumab Plus Best Supportive Care vs. Placebo Plus Best Supportive Care as Second-Line Therapy in Asian Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-394)Results posted
- 2026-07-15A PHASE 2, OPEN-LABEL STUDY OF IRPAGRATINIB IN COMBINATION WITH ATEZOLIZUMAB AND BEVACIZUMAB IN PATIENTS WITH ADVANCED OR UNRESECTABLE HEPATOCELLULAR CARCINOMA (IAPETUS)Results expected Q1 2029
- 2026-01-20Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular CarcinomaResults expected Q2 2027
- 2026-07-15ClinicalA PHASE 2, OPEN-LABEL STUDY OF IRPAGRATINIB IN COMBINATION WITH ATEZOLIZUMAB AND BEVACIZUMAB IN PATIENTS WITH ADVANCED OR UNRESECTABLE HEPATOCELLULAR CARCINOMA (IAPETUS)Results expected Q1 2029
- 2026-06-18ClinicalA Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or AblationResults posted
- 2026-03-26ClinicalA 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)Completed
- 2026-02-26ClinicalA Phase III, Multicenter, Randomized, Open-label Trial to Evaluate the Safety and Efficacy of Systemic Therapy With Regorafenib and Pembrolizumab Versus Locoregional Therapy With Transarterial Chemoembolization or Transarterial Radioembolization, for the First-line Treatment of Intermediate-stage Hepatocellular Carcinoma With Beyond Up-to-7 CriteriaTerminated
- 2026-02-05ClinicalA Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)Results posted
- 2026-01-20ClinicalTislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular CarcinomaResults expected Q2 2027
- 2026-01-01ResearchMetabolic Dysfunction-Associated Steatotic Liver Disease in Adults: A Review.Tilg H · 2026
- 2025-09-30ClinicalA Phase III Randomized Double-blind Study of Pembrolizumab Plus Best Supportive Care vs. Placebo Plus Best Supportive Care as Second-Line Therapy in Asian Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-394)Results posted
- 2025-09-26ResearchCombination immunotherapy in hepatocellular carcinoma: synergies among immune checkpoints, TKIs, and chemotherapy.Dai S · 2025
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Imjudo in combination with durvalumab is indicated for the first line treatment of a… (2023)
Approval — Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular… (2022)
Approval — Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy… (2018)
Approval — Urothelial carcinoma Tecentriq as monotherapy is indicated for the treatment of adul… (2017)
Accelerated approval — Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell… (2016)
Approval — Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of a… (2014)
Approval — Stivarga is indicated as monotherapy for the treatment of adult patients with: metastati… (2013)
Approval — Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatme… (2011)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Carcinoma, Hepatocellular47
- Liver Neoplasms47
- Gastrointestinal Microbiome8
- Immune Checkpoint Inhibitors8
- Immunotherapy5
- Non-alcoholic Fatty Liver Disease4
- Diabetes Mellitus, Type 23
- Drug Resistance, Neoplasm3
Leading journals6
- Frontiers in immunology6
- Journal of hematology & oncology6
- Hepatology (Baltimore, Md.)5
- International journal of molecular sciences4
- Journal of experimental & clinical cancer research : CR4
- Gastroenterology3
Leading researchers8
- Llovet JM7
- Zhang Y6
- Finn RS5
- Kudo M5
- Li Y5
- Zhang J5
- Zhu AX5
- Chen X4
Affiliations (unnormalised)6
- Tisch Cancer Institute5
- Humanitas University4
- Kindai University Faculty of Medicine4
- The First Affiliated Hospital4
- Mayo Clinic3
- Memorial Sloan Kettering Cancer Center3
Disease biology
Key proteins & gene products studied in this disease. Number shows shared papers.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Hepatocellular carcinoma is a primary malignant tumor arising from epithelial liver cells and is the most common form of liver cancer. It can range from well-differentiated tumors that resemble normal hepatocytes to poorly differentiated neoplasms with pleomorphic or giant cells.
The main established causes are infection with hepatitis B virus and hepatitis C virus. Non-alcoholic steatohepatitis associated with metabolic syndrome or diabetes mellitus is also described as an increasingly frequent cause in Western populations.
The disease is characterized by malignant transformation of hepatocytes and is influenced by the immune system, tumor microenvironment, signal transduction, gene expression regulation, and tumor escape. The literature also highlights genetic alterations such as TERT promoter mutations, VEGFA and FGF19/CNND1 amplifications, and TP53 and CTNNB1 mutations, as well as roles for microRNAs and drug resistance.
Chronic hepatitis B and hepatitis C infection are major risk factors. Non-alcoholic steatohepatitis, metabolic syndrome, and diabetes mellitus are also associated with increased risk.
Systemic therapy for advanced disease has historically included antiangiogenic tyrosine kinase inhibitors such as sorafenib, regorafenib, and lenvatinib. More recent standard treatment includes immunotherapy with checkpoint inhibitors, particularly anti-PD-1/PD-L1 approaches, and combinations such as an anti-PD-L1 antibody with bevacizumab.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
A primary malignant neoplasm of epithelial liver cells. It ranges from a well-differentiated tumor with EPITHELIAL CELLS indistinguishable from normal HEPATOCYTES to a poorly differentiated neoplasm. The cells may be uniform or markedly pleomorphic, or form GIANT CELLS. Several classification schemes have been suggested.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.