This is a prospective, non-randomized, open-label, single-center phase II clinical trial. It aims to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (DST) to guide personalized systemic therapy for patients with unresectable hepatocellular carcinoma (HCC). A total of 94 eligible patients will be enrolled and grouped based on patient preference into either the Organoid-Directed Therapy group or the Control group (standard therapy). Tumor tissues obtained via biopsy will be used to establish organoid cultures. Drug sensitivity testing will be performed on a pre-defined panel of approved regimens (including Atezolizumab + Bevacizumab, Sintilimab + Bevacizumab biosimilar, Apatinib + Camrelizumab, Donafenib, Lenvatinib, Tislelizumab, Sorafenib, and FOLFOX4) to identify the most effective treatment. Patients for whom organoid construction fails or valid DST results are unavailable within one month will cross over to the control group to receive standard therapy. The co-primary endpoints are Objective Response Rate (ORR) and Progression-Free Survival (PFS), both assessed according to RECIST 1.1. Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel, personalized treatment strategy to improve outcomes for patients with advanced, unresectable HCC.
Male or female, aged between 18 and 70 years (inclusive).
Diagnosis of primary liver cancer confirmed according to the diagnostic criteria of the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer.
The subject or their legal guardian understands and voluntarily signs the Informed Consent Form, and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures as required by the protocol.
Life expectancy of at least 6 months.
Uncorrectable coagulopathy or individuals with a significant bleeding tendency.
Evidence of any concurrent malignant disease.
Diagnosis of another malignancy within 3 years prior to the first dose, except for radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or carcinoma in situ that has undergone curative resection.
Patients requiring long-term anticoagulant or antiplatelet therapy that cannot be discontinued.
Single group
Organoid Drug Sensitivity Testing-Guided Therapy
DrugFresh tumor tissue from resection is used to establish and culture patient-derived organoids. Successful organoids undergo drug sensitivity testing against a predefined panel of drugs (Atezolizumab + Bevacizumab, Sintilimab + Bevacizumab Biosimilar,Apatinib+ Camrelizumab, Donafenib, Lenvatinib, Tislelizumab, Sorafenib, FOLFOX4). The most effective drug(s), based on IC50 and AUC values, are recommended for treatment.
Objective Response Rate(ORR)
Progression-free Survival(PFS)
In treated subjects, the time from first recording to tumor progression (based on RECIST 1.1 and mRECIST) or death from any cause.
Overall Survival(OS)
Adverse event
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