Hepatocellular Carcinoma (HCC)Phase 2NCT07413354
Tislelizumab Combined With Huaier Granule as First-line Treatment for Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Tislelizumab plus Huaier granule in people with Hepatocellular Carcinoma (HCC), run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Tislelizumab plus Huaier granule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Any severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy at screening (e.g., tuberculosis), excluding viral hepatitis; known history of human immunodeficiency virus infection;
- Presence of underlying medical conditions that, in the investigator's judgment, may pose risks for receiving the study treatment or complicate the interpretation of adverse events/toxicity;
- History of allogeneic stem cell transplantation or organ transplantation; receipt of any live vaccine within 4 weeks before randomization (Note: seasonal influenza vaccines are generally inactivated and allowed; intranasal vaccines are live and not allowed);
- Any major surgery within 28 days before randomization;
- Female patients who are lactating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, No. 1095, Jiefang Avenue, Wuhan 430030, Hubei, China
Wuhan, Hubei, 430030
Qi Cheng, MD, PhD, +86 13871459541, chengqi@hust.edu.cn
About this study
Official title: Tislelizumab Combined With Huaier Granule as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Prospective Clinical Trial
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)
- Being tested
- Tislelizumab plus Huaier granule
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab plus Huaier granuleDrug
Tislelizumab Combined with Huaier Granule as First-Line Therapy for Unresectable Hepatocellular Carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab plus Huaier granule | Experimental | Not described Receives: Drug: Tislelizumab plus Huaier granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Disease Control Rate
Measured: through study completion, an average of 1 year
Progression-Free Survival
Measured: 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
Measured: From date of treatment until the date of death from any cause, assessed up to 100 months
Duration of Response
Measured: 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
Measured: Within 30 days following the final administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Apr 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Qi, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413354
- Sponsor's protocol ID
- TCH-HCC
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ORR, DCR, PFS, OS
Publications
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.
PubMed 30449599Long 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.
PubMed 37449208Chen 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.
PubMed 29802174Ren 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.
PubMed 34143971Hashimoto 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.
PubMed 41607859Qin 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.
PubMed 37796513Xia 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.
PubMed 35143424Sung 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.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined With Huaier Granule as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07413354
- Acronym / sponsor ID
- TCH-HCC
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab plus Huaier granule | Experimental | Drug: Tislelizumab plus Huaier granule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab plus Huaier granuleTislelizumab Combined with Huaier Granule as First-Line Therapy for Unresectable Hepatocellular Carcinoma | Drug | Tislelizumab plus Huaier granule |
Primary outcome
Objective Response Rate
Time frame: through study completion, an average of 1 year
5 secondary outcomes
Disease Control Rate
Time frame: through study completion, an average of 1 year
Progression-Free Survival
Time frame: 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
Time frame: From date of treatment until the date of death from any cause, assessed up to 100 months
Duration of Response
Time frame: 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
Time frame: Within 30 days following the final administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Results publication: PubMed 30449599Teixeira 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 publication: PubMed 37449208Long 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 publication: PubMed 29802174Chen 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 publication: PubMed 34143971Ren 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 publication: PubMed 41607859Hashimoto 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 publication: PubMed 37796513Qin 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 publication: PubMed 35143424Xia 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 publication: PubMed 33538338Sung 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.
- Individual participant dataSharing planned: Yes. ORR, DCR, PFS, OS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab plus Huaier granule in people with Hepatocellular Carcinoma (HCC), run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Cheng, MD, PhD (+86 13871459541, chengqi@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07413354, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.