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:
Complete blood count (without blood transfusion or use of granulocyte colony-stimulating factor [G-CSF] within 14 days prior to screening):
Hemoglobin ≥90 g/L;
Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
Platelet count ≥75×10⁹/L;
- Blood biochemistry (without albumin use within 14 days prior to screening):
Albumin ≥28 g/L;
Total bilirubin ≤2× upper limit of normal (ULN);
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× ULN;
Alkaline phosphatase (ALP) ≤5× ULN;
Creatinine ≤1.5× ULN;
- Coagulation function:
International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN;
Activated partial thromboplastin time (APTT) ≤1.5× ULN.
Exclusion Criteria:
wang.zheng@zs-hospital.sh.cn+86 021 6404 1990
Donafenib +PD-1/L1+TACE
Donafenib +PD-1/L1+HAIC
xiakanfanxing@163.com+86 0451 8629 8666
A Single Center Study of Donafenib Combined With PD-1 + TACE in the First-line Treatment of aHCC
Donafenib Combine With Sintilimab and HAIC (Hepatic Artery Infusion Chemotherapy,HAIC)in the First-line Treatment of Unresectable Hepatocellular Carcinoma
Sequential Transarterial Chemoembolization (TACE), Stereotactic Body Radiation Therapy (SBRT), and Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma Treated With Donafenib
Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery
Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy
A Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCC
Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma
Efficacy and Safety of Transarterial Therapies+Donafenib + Anti-PD-1 Antibody for uHCC: A Retrospective Real-world Study