Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2024
FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 2 of them syntheses that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
52 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- Locoregional therapy combined with targeted therapy and immunotherapy for hepatocellular carcinoma with portal vein tumor thrombosis: a systematic review and meta-analysis.Scientific reports · 2025Pooled it
- A bibliometric and visual analysis based on immune checkpoint inhibitors for hepatocellular carcinoma: 2014 - 2024.Frontiers in pharmacology · 2025Pooled it
- Targeting Immune Checkpoint Proteins in Cancer Therapy and the Potential of RNAi-Based Immunotherapy.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Combination Immunotherapy as a Promising Strategy to Overcome Immunotherapy Resistance: From Emergence to Next-Generation Approaches.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Review
- Review
- Immune Checkpoint-Based Therapies in Colorectal Cancer-Current Approaches and Future Perspectives.International journal of molecular sciences · 2026Review
- Oncofetal reprogramming in hepatocellular carcinoma: linking developmental programs to cancer vaccines and immunotherapy.Clinical and molecular hepatology · 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
- Bone Adverse Events in Cancer Patients Undergoing Immune Checkpoint Inhibitor Therapy: A Comprehensive Review of the Literature from the Clinical Action Group of the European Calcified Tissue Society.Calcified tissue international · 2026Review
- Immune checkpoint blockade in cancer: current insights and future horizons.Discover oncology · 2026Review
- Regulatory T-cell remodeling across the HBV infection-cirrhosis continuum.Frontiers in immunology · 2026Review
- Spatial Treg niches and the therapeutic reprogramming of tumour tolerance in cancer.Frontiers in cell and developmental biology · 2026Review
- Synergistic Strategies in Systemic Therapy for Advanced Hepatocellular Carcinoma.Global challenges (Hoboken, NJ) · 2026Review
- Deficiencies in germline DNA repair are associated with early-onset gastrointestinal cancers and inform precision prevention strategies.Journal of translational medicine · 2025Article
- Immune biomarkers for head and neck cancer.Cancer immunology, immunotherapy : CII · 2025Review
- Immune checkpoint biology in hepatocellular carcinoma (Review).Oncology letters · 2025Review
- Targeting CXCR6 Disrupts β-Catenin Signaling and Enhances Sorafenib Response in Hepatocellular Carcinoma.Cancers · 2025Article
- Article
- Discovery of novel disulfide-containing PD-1/PD-L1 inhibitor with in vivo influenza therapeutic efficacy.Scientific reports · 2025Article
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 2 institutions in 1 country.
Funding
Abstract
On October 21, 2022, the FDA approved tremelimumab (Imjudo) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma. The approval was based on the results from the HIMALAYA study, in which patients with unresectable hepatocellular carcinoma who were naïve to previous systemic treatment were randomly assigned to receive one of three study arms: tremelimumab in combination with durvalumab (n = 393), durvalumab (n = 389), or sorafenib (n = 389). The primary objective of improvement in overall survival (OS) for tremelimumab in combination with durvalumab compared with sorafenib met statistical significance with a stratified HR of 0.78 [95% confidence interval (CI), 0.66-0.92; P = 0.0035]. The median OS was 16.4 months (95% CI, 14.2-19.6) with tremelimumab in combination with durvalumab and 13.8 months (95% CI, 12.3-16.1) with sorafenib. Adverse reactions occurring in ≥20% of patients receiving tremelimumab in combination with durvalumab were rash, fatigue, diarrhea, pruritus, musculoskeletal pain, and abdominal pain. The recommended tremelimumab dose for patients weighing 30 kg or more is 300 mg, i.v., as a single dose in combination with durvalumab 1,500 mg at cycle 1/day 1, followed by durvalumab 1,500 mg, i.v., every 4 weeks. For those weighing less than 30 kg, the recommended tremelimumab dose is 4 mg/kg, i.v., as a single dose in combination with durvalumab 20 mg/kg, i.v., followed by durvalumab 20 mg/kg, i.v., every 4 weeks.
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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.