Electronic Journal of Liver Tumor ›› 2024, Vol. 11 ›› Issue (4): 1-5.

• Special topic •     Next Articles

Progress summary clinical trials of new drugs for liver cancer

Sun Jiayang1, Hu Wei2, Tang Yu3,*   

  1. 1. Zunyi Medical University, Zunyi 563006,Guizhou, China;
    2. Department of Oncology, Hospital of Zunyi Medical University, Early Clinical Research Ward, Hospital of Zunyi Medical University, Zunyi 563000, Guizhou, China;
    3. National Cancer Center / National Clinical Research Center for Cancer / Drug Clinical Trial Research Center of Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100021, China
  • Received:2024-12-24 Online:2024-12-30 Published:2025-02-25
  • Contact: *Tang Yu, E-mail: tangyu@cicams.ac.cn

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Abstract: Objective: To summarize the development trend of global clinical trials of primary hepatic cancer(HCC) from 2020 to June 2024.
Methods: Based on the Trialtrove database developed by Informa Pharma Intelligence (London, UK), the clinical trials of liver cancer and the related medicines launched from 2020 to 2024 were extracted. The annual growth rate, the characteristics of trials and tested products were analyzed.
Results: During the statistical period, a total of 356 clinical trials for HCC were carried out worldwide, accounting for 4.3% of all anti-cancer clinical trials. Among them, 189 (53.1%) were initiated by domestic companies. The number of clinical trials for HCC peaked in 2022 (101 trials). Phase I(including phase Ⅰ/Ⅱ) clinical trials were the most common trial phase type (266 trials, 74.7%). In terms of trial indications, drug development for advanced HCC accounted for the highest proportion (324 trials, 91.0%). Among all the investigational drugs, the types of drugs involved mainly included antibody drugs (48.0%), small molecule targeted drugs (25.4%), cell and gene therapy (15.4%) and antibody-drug conjugate (5.0%). Thirty-two clinical trials focused on first line treatment for late-stage HCC. Among them, the main investigational treatment modality was combined immunotherapy based on immune checkpoint inhibitors. A total of 262 clinical trials were conducted for patients with advanced HCC progressed after previous treatment, of which 32 trials (12.2%) were carried out in patients failed immunotherapy. All the 32 trials were in phase Ⅰ/Ⅱ trials, involving a variety of experimental drug types.
Conclusions: The clinical development of liver cancer drugs is active in the world, and domestic enterprises play an important role. In liver cancer, immunotherapy is the most active field of drug development. While in the clinical trials including heavily treated HCC patients, cell and gene therapy is also an important clinical research area. It is suggested that domestic enterprises should increase investment in the development of novel drugs for liver cancer, explore more new targets and drugs with new mechanisms, and broaden the possible directions of liver cancer treatment.

Key words: Liver cancer, Drugs, Clinical trial, Immunotherapy, Cellular gene therapy