RecruitingPhase 2NCT07413354

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

Tislelizumab Combined With Huaier Granule as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Prospective Clinical Trial


Sponsor

Tongji Hospital

Enrollment

94 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining tislelizumab (an immunotherapy drug that helps the immune system fight cancer) with Huaier Granule (a traditional Chinese herbal medicine) works better than tislelizumab alone as a first-line treatment for liver cancer (hepatocellular carcinoma) that cannot be surgically removed. **You may be eligible if...** - You are 18 or older - You have confirmed liver cancer (hepatocellular carcinoma or HCC) at an advanced or intermediate stage not suitable for surgery or local treatment - You have not received any prior systemic (whole-body) therapy for liver cancer - You have at least one measurable tumor by imaging - Your liver function is good (Child-Pugh class A) - Your overall health is adequate (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer involves a blood clot in the main portal vein or inferior vena cava - You have a rare type of liver cancer (fibrolamellar, sarcomatoid, or mixed with bile duct cancer) - You have recently had local liver treatments or immunotherapy (within 28 days) - You have active autoimmune disease requiring immune-suppressing therapy - You have had significant bleeding from varices (enlarged veins in the esophagus or stomach) within 6 months - You are breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab plus Huaier granule

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


Locations(1)

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

Wuhan, Hubei, China

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NCT07413354


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