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

May 7, 2026 updated by: Cheng Qi, Tongji Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female aged ≥18 years at the time of signing the informed consent form;
  2. Histologically confirmed diagnosis of HCC;
  3. 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;
  4. No prior systemic therapy for HCC. Note: Patients who have previously received local therapy (e.g., TACE) are not excluded;
  5. 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;
  6. Child-Pugh class A liver function within 7 days prior to randomization;
  7. ECOG performance status ≤1.

Exclusion Criteria:

  1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular-cholangiocarcinoma;
  2. Tumor thrombus involving the main portal vein or inferior vena cava;
  3. 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;
  4. Use of traditional Chinese medicine or patent drugs for cancer control within 14 days before enrollment;
  5. Grade 2 or higher hepatic encephalopathy at screening or in medical history;
  6. 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;
  7. History of severe hypersensitivity to other monoclonal antibodies;
  8. Any clinical evidence of portal hypertension with bleeding esophageal or gastric varices during screening or within 6 months before randomization;
  9. Toxicities from prior anticancer therapy have not resolved to baseline or stabilized, except for alopecia;
  10. 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);
  11. 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);
  12. Known central nervous system metastases and/or leptomeningeal disease at screening;
  13. Any active immunodeficiency or autoimmune disease at screening, and/or history of any immunodeficiency or autoimmune disease with potential for recurrence;
  14. 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;
  15. History of interstitial lung disease or non-infectious pneumonia, unless radiation-induced;
  16. 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;
  17. 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;
  18. 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);
  19. Any major surgery within 28 days before randomization;
  20. Female patients who are lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tislelizumab plus Huaier granule
Drug: Tislelizumab plus Huaier granule
Tislelizumab Combined with Huaier Granule as First-Line Therapy for Unresectable Hepatocellular Carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease Control Rate
Time Frame: through study completion, an average of 1 year
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
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
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.
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.
Within 30 days following the final administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCH-HCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

ORR, DCR, PFS, OS

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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