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Evolution of Clinical Trials of Systemic Therapies for Hepatocellular Carcinoma Between 2005 and 2024: Based on

Yinghong Zhou1, Siyu Sun2, Ying Zhang2

  • 1Science and Information Center, Library, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Gastro Hep Advances
|September 12, 2025
PubMed

Insights

Clinical trials for hepatocellular carcinoma (HCC) systemic therapies have significantly advanced, particularly in immunotherapy and targeted treatments. Research shows a notable increase in trial registrations and a shift towards combination therapies over the past two decades.

Area of Science:

  • Oncology
  • Clinical Trial Analysis
  • Hepatocellular Carcinoma (HCC) Therapeutics

Background:

  • Hepatocellular carcinoma (HCC) remains a significant global health challenge, necessitating continuous advancements in systemic therapies.
  • Understanding the landscape and evolution of clinical trials is crucial for optimizing future research and treatment strategies for HCC.

Purpose of the Study:

  • To evaluate the fundamental characteristics of clinical trials for systemic therapies in hepatocellular carcinoma (HCC).
  • To analyze the changes and trends in HCC clinical trial designs and interventions over the past two decades (2005-2024).

Main Methods:

  • Systematic download and analysis of interventional clinical trials for HCC systemic therapies registered on ClinicalTrials.gov from January 2005 to December 2024.
  • Evaluation of key trial parameters including recruitment status, clinical phase, intervention type, trial design, and outcome indicators.
  • Categorization and quantitative analysis of 1233 registered trials based on these parameters.

Main Results:

  • A substantial increase in HCC trial registrations was observed, with 70.6% registered between 2015-2024 compared to 29.4% from 2005-2014.
  • Immune monotherapies (35.2%) and small-molecule targeted agents (29.5%) were the predominant interventions, followed by combination therapies (23.3%).
  • Phase 2 trials constituted the largest proportion (45.4%), with a notable focus on immune checkpoint inhibitors, particularly PD-1/PD-L1 antibodies.

Conclusions:

  • The development of systemic therapies for HCC has progressed significantly, marked by a surge in clinical trials and a growing emphasis on immunotherapy and targeted agents.
  • The findings underscore the importance of immunotherapy and targeted therapy in HCC treatment paradigms.
  • This study provides a valuable reference for refining future HCC therapeutic development, clinical trial design, and treatment strategies.
Keywords:
Checkpoint inhibitorChimeric antigen receptor T cell therapyClinical trialHepatocellular carcinomaImmunotherapyPrimary endpointSmall molecular target therapy

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