Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage Hepatocellular Carcinoma Out Up-to-seven: a Multi-center Randomized Controlled Trial.
The purpose of this study is to evaluate the safety and efficacy of the combination therapy with HAIC-TACE and donafenib compared to TACE plus donafenib in patients with BCLC B stage unresectable hepatocellular carcinoma (HCC) out of up-to-seven criteria.
• Subjects must volunteer to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures.
• Age and gender: \>18 years old and≤75 years old, both men and women.
• All subjects must have Hepatocellular Carcinoma confirmed by pathological or clinical diagnosis.
• Subjects are not suitable for radical resection or radical ablative therapy.
• BCLC B based on Barcelona Clinic Liver Cancer staging system, and the lesions in the liver exceed up to 7 criteria, the number of tumors + the maximum diameter of tumors \> 7.
• Patients with viable and measurable target lesion per mRECIST.
• Patients who are expected to live more than 3 months.
• ECOG PS 0-1.
• Child-Pugh class A.
⁃ Patients with laboratory values that meet the following criteria:
∙ Hemoglobin≥90 g/L;
‣ Neutrophile granulocytes≥1.5×109/L;
‣ Platelet count≥75×109/L;
‣ Albumin≥30 g/L;
‣ Total serum bilirubin ≤ 2 times upper limits of normal;
‣ AST and ALT ≤ 5 times upper limits of normal;
‣ Serum creatinine ≤ 1.5 times upper limits of normal;
‣ Alkaline phosphatase ≤ 5 times upper limits of normal;
‣ Prothrombin time or international normalized ratio ≤ 1.5 times upper limits of normal, activated partial thromboplastin time (APTT) ≤ 1.5×ULN;