SIRT (Yttrium-90 Carbon Microspheres) Versus cTACE for Unresectable Hepatocellular Carcinoma: A Multicenter, Prospective, Open-label, Phase 3 Trial (CHANCE2506)
To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma
• Eastern Cooperative Oncology Group performance status ≤ 1;
• Expected survival time ≥ 3 months;
• Confirmed hepatocellular carcinoma based on CNLC guidelines;
• Without extrahepatic metastases, unresectable or refuse surgical resection;
• At least one well defined tumor (mRECIST 1.1);
• Tumor burden≤50% of the total liver volume;
• Child-Pugh score≤7;
• Adequate organ function: # Blood routine: absolute neutrophil count ≥ 1.5×10\^9/L; platelet≥75×10\^9/L; hemoglobin≥90 g/L; # Liver function: total bilirubin≤2 times upper limit of normal (ULN); alanine transaminase and aspartate aminotransferase≤5.0 ULN; alkaline phosphatase≤2.5 ULN; Albumin\>30 g/L; # Renal function: Cr≤1.5 ULN; creatinine clearance≥50 mL/min; # Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN;
• Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 m after the end of the trial.