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

NCT07413354 | Recruiting Phase 2 DMC

• 1 other identifier: TCH-HCC
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Disease Control Rate

  through study completion, an average of 1 year

• Progression-Free Survival

  From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• Overall Survival

  From date of treatment until the date of death from any cause, assessed up to 100 months

• Duration of Response

  From date of documented objective tumor response until the date of the first recorded disease progression or death from any cause, whichever occurs first, assessed up to 100 months.

• Incidence of Adverse Events

  Within 30 days following the final administration.

Study Arms (1)

Tislelizumab plus Huaier granule

EXPERIMENTAL

Drug: Tislelizumab plus Huaier granule

Interventions

Tislelizumab plus Huaier granule DRUG

Tislelizumab Combined with Huaier Granule as First-Line Therapy for Unresectable Hepatocellular Carcinoma

Tislelizumab plus Huaier granule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥18 years at the time of signing the informed consent form;
• Histologically confirmed diagnosis of HCC;
• BCLC stage C, or BCLC stage B disease that is unsuitable for locoregional therapy or has progressed after locoregional therapy, and is not eligible for curative treatment;
• No prior systemic therapy for HCC. Note: Patients who have previously received local therapy (e.g., TACE) are not excluded;
• Presence of ≥1 measurable lesion according to RECIST v1.1, provided that: the selected target lesion(s) have not been previously treated with local therapy, or the selected target lesion(s) are located within an area of prior local treatment and have subsequently been assessed as progressive disease according to RECIST v1.1;
• Child-Pugh class A liver function within 7 days prior to randomization;
• ECOG performance status ≤1.

You may not qualify if:

• Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular-cholangiocarcinoma;
• Tumor thrombus involving the main portal vein or inferior vena cava;
• Prior local liver therapy (e.g., transarterial chemoembolization, transarterial embolization, hepatic arterial infusion, radiotherapy, radioembolization, or ablation) or any immunotherapy (e.g., interleukin, interferon, thymosin, etc.) within 28 days before enrollment;
• Use of traditional Chinese medicine or patent drugs for cancer control within 14 days before enrollment;
• Grade 2 or higher hepatic encephalopathy at screening or in medical history;
• Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites at screening, defined as meeting either of the following criteria: (a) ascites detectable by physical examination at screening, or (b) ascites requiring paracentesis during screening;
• History of severe hypersensitivity to other monoclonal antibodies;
• Any clinical evidence of portal hypertension with bleeding esophageal or gastric varices during screening or within 6 months before randomization;
• Toxicities from prior anticancer therapy have not resolved to baseline or stabilized, except for alopecia;
• Any hemorrhagic or thrombotic disease within 6 months before screening, or any anticoagulant therapy requiring monitoring of the international normalized ratio (e.g., warfarin or similar agents);
• History of any active malignancy within 2 years before screening, except for HCC under study in this trial and locally recurrent cancers that have been curatively treated (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast);
• Known central nervous system metastases and/or leptomeningeal disease at screening;
• Any active immunodeficiency or autoimmune disease at screening, and/or history of any immunodeficiency or autoimmune disease with potential for recurrence;
• Any condition requiring systemic corticosteroid therapy (at doses \>10 mg/day prednisone or equivalent of similar drugs) or other immunosuppressive treatment within 14 days before screening;
• History of interstitial lung disease or non-infectious pneumonia, unless radiation-induced;

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, No. 1095, Jiefang Avenue, Wuhan 430030, Hubei, China

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 30449599 RESULT

• 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.

  PMID: 37449208 RESULT

• 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.

  PMID: 29802174 RESULT

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Qi Cheng, MD, PhD

CONTACT

+86 13871459541; chengqi@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)