Health TrialsbyHealthPanel

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

ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab plus Huaier granule

    Drug

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

Treatment groups

94 Participants
are divided into 1 treatment group
Group A: Tislelizumab plus Huaier granuleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Disease Control Rate

Time frame
through study completion, an average of 1 year
2

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
3

Overall Survival

Time frame
From date of treatment until the date of death from any cause, assessed up to 100 months
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov
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