SIRT Versus cTACE for Unresectable HCC (CHANCE2506)

Prior treatment

• With previous history of hepatic encephalopathy;
• With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy;
• The single lung radiation absorbed dose\>30 Gy;

Other illness

• Extrahepatic disease or combined with other malignant tumors;
• Allergy to contrast agents or anesthetics
• With clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis, or moderate-to-severe esophageal/gastric varices;
• With severe pulmonary insufficiency (forced expiratory volume at one second / forced vital capacity\<50% or forced expiratory volume at one second /predicting value\<50% or maximum volume per minute\<50 L/min);
• Serious infections in active stage or need systematic treatment;
• With positive results of HIV antibody test;
• HBV DNA or HCV RNA positive;
• With active syphilis or tuberculosis;
• 99mTc-MAA imaging (patients exclusion meet all criteria):
  • 1\) Perfusion area covers all intrahepatic tumors (including non-target lesions) and non-perfused liver volume ≥30% of total liver volume; 2) Tumor dose ≥400 Gy for 1-2 hepatic segments; Perfused normal liver dose (PNLD): 120 Gy \< PNLD \<1000 Gy; Tumor dose ≥200 Gy (recommended ≥400 Gy) and PNLD \<120 Gy with other condition; 3) No gastrointestinal shunt , or shunt amendment by endovascular techniques (reassessment required); 4) cTACE should cover all intrahepatic lesions.

Other

• Infiltrative hepatocellular carcinoma ;
• With hepatic artery malformation and unable to undergo TACE or SIRT;
• Tumor thrombus in main portal vein or hepatic artery or hepatic vein or bile duct;
• Pregnant and lactating women;

• 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.