Tislelizumab Combined With Huaier Granule as First-line Treatment for Unresectable Hepatocellular Carcinoma

Summary

This study is a single-arm prospective clinical trial that enrolled 94 patients with unresectable hepatocellular carcinoma(HCC) who received first-line treatment with tislelizumab combined with Huaier granule. By comparing the objective response rate (ORR) and other data with those from the historical Rational 301 study, the study aims to explore the efficacy and safety of tislelizumab combined with Huaier granule as a first-line treatment for unresectable HCC, as well as its potential to improve patients' quality of life and alleviate HCC-related symptoms.

Timeline

Start

2026-04-01

Primary completion

2027-03-31

Completion

2027-12-30

Publications

• Results Teixeira JD, de Andrade Rosa I, Brito J, Maia de Souza YR, Paulo de Abreu Manso P, Machado MP, Costa ML, Mermelstein C. Sonic Hedgehog signaling and Gli-1 during embryonic chick myogenesis. Biochem Biophys Res Commun. 2018 Dec 9;507(1-4):496-502. doi: 10.1016/j.bbrc.2018.11.071. Epub 2018 Nov 16.
• Results Long H, Wu Z. Immunoregulatory effects of Huaier (Trametes robiniophila Murr) and relevant clinical applications. Front Immunol. 2023 Jun 28;14:1147098. doi: 10.3389/fimmu.2023.1147098. eCollection 2023.
• Results Chen Q, Shu C, Laurence AD, Chen Y, Peng BG, Zhen ZJ, Cai JQ, Ding YT, Li LQ, Zhang YB, Zheng QC, Xu GL, Li B, Zhou WP, Cai SW, Wang XY, Wen H, Peng XY, Zhang XW, Dai CL, Bie P, Xing BC, Fu ZR, Liu LX, Mu Y, Zhang L, Zhang QS, Jiang B, Qian HX, Wang YJ, Liu JF, Qin XH, Li Q, Yin P, Zhang ZW, Chen XP. Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial. Gut. 2018 Nov;67(11):2006-2016. doi: 10.1136/gutjnl-2018-315983. Epub 2018 May 25.
• Results Ren Z, Xu J, Bai Y, Xu A, Cang S, Du C, Li Q, Lu Y, Chen Y, Guo Y, Chen Z, Liu B, Jia W, Wu J, Wang J, Shao G, Zhang B, Shan Y, Meng Z, Wu J, Gu S, Yang W, Liu C, Shi X, Gao Z, Yin T, Cui J, Huang M, Xing B, Mao Y, Teng G, Qin Y, Wang J, Xia F, Yin G, Yang Y, Chen M, Wang Y, Zhou H, Fan J; ORIENT-32 study group. Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study. Lancet Oncol. 2021 Jul;22(7):977-990. doi: 10.1016/S1470-2045(21)00252-7. Epub 2021 Jun 15.
• Results Hashimoto K, Kawaoka T, Emori T, Tanaka A, Shirane Y, Miura R, Fujii Y, Nakahara H, Yamaoka K, Uchikawa S, Fujino H, Ono A, Murakami E, Miki D, Hayes CN, Hiramatsu A, Amioka K, Nonaka M, Aisaka Y, Morio K, Moriya T, Teraoka Y, Kono H, Suehiro Y, Masaki K, Ohya K, Takaki S, Mori N, Tsuji K, Kosaka Y, Nakahara T, Aikata H, Tsuge M, Oka S. Atezolizumab plus Bevacizumab with Transcatheter Arterial Chemoembolization (Sandwich Strategy) versus Atezolizumab plus Bevacizumab Alone in Hepatocellular Carcinoma: A Multicenter Retrospective Study. Liver Cancer. 2025 Dec 9. doi: 10.1159/000549979. Online ahead of print.
• Results Qin S, Kudo M, Meyer T, Bai Y, Guo Y, Meng Z, Satoh T, Marino D, Assenat E, Li S, Chen Y, Boisserie F, Abdrashitov R, Finn RS, Vogel A, Zhu AX. Tislelizumab vs Sorafenib as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Dec 1;9(12):1651-1659. doi: 10.1001/jamaoncol.2023.4003.
• Results Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108.
• Results Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

Drugs

Indications