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.
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;
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;