The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus TACE) or HAIC as First-line Treatment for Unresectable Hepatocellular Carcinoma A Multi-center, Retrospective Clinical Study

This is a multicenter, retrospective study planned to enroll patients with unresectable hepatocellular carcinoma (uHCC) who received first-line donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC at 8 sites between June 1, 2021 and November 30, 2024. The study consists of two cohorts: Cohort A consists of patients who received donafenib + PD-1/L1 inhibitor + TACE, and Cohort B consists of patients who received donafenib + PD-1/L1 inhibitor + HAIC, with a planned enrollment of 200 patients per cohort. Relevant data will be collected to evaluate the efficacy and safety of donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC in the treatment of uHCC in real-world clinical practice.

Inclusion Criteria: * Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, an anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC), with retrievable records in the hospital electronic information system between June 1, 2021 and November 30, 2024. * Diagnosis of hepatocellular carcinoma confirmed by the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) clinically or by histology/cytology. * Age ≥18 years, regardless of sex. * No prior systemic therapy before the administration of donafenib, anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC). * The maximum interval between the initiation of donafenib, anti-PD-1/L1 monoclonal antibody, and transarterial interventional therapy (TACE or HAIC) does not exceed 8 weeks, and at the time the last of these treatment modalities is initiated, the subject must not have experienced disease progression. * For patients who have previously undergone hepatectomy, the resection must be R0, and tumor recurrence must have occurred more than 24 months after surgery. * At least one evaluable lesion (according to RECIST v1.1 criteria). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1. * Child-Pugh class A or B. * Adequate major organ function, defined by the following criteria: Complete blood count (without blood transfusion or use of granulocyte colony-stimulating factor \[G-CSF\] within 14 days prior to screening): 1. Hemoglobin ≥90 g/L; 2. Absolute neutrophil count (ANC) ≥1.5×10⁹/L; 3. Platelet count ≥75×10⁹/L; \- Blood biochemistry (without albumin use within 14 days prior to screening): 4. Albumin ≥28 g/L; 5. Total bilirubin ≤2× upper limit of normal (ULN); 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× ULN; 7. Alkaline phosphatase (ALP) ≤5× ULN; 8. Creatinine ≤1.5× ULN; \- Coagulation function: 9. International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN; 10. Activated partial thromboplastin time (APTT) ≤1.5× ULN. Exclusion Criteria: * Incomplete or unavailable patient information data; patient refused follow-up or was lost to follow-up; * Duration of donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy was less than 1 month; * Prior histologically/cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components; * History of malignancy other than hepatocellular carcinoma, unless meeting the following criteria: a) The patient received potentially curative treatment and there has been no evidence of disease for 5 years; b) Successfully treated resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ;