NCT06909708 SIRT Versus cTACE for Unresectable HCC (CHANCE2506)

Eligibility & Interventions

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This trial targets 108 participants in total. It began in 2025-04-03 with a primary completion date of 2026-12-31.

Brief Summary

To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma

Eligibility Criteria

Inclusion Criteria: 1. Eastern Cooperative Oncology Group performance status ≤ 1; 2. Expected survival time ≥ 3 months; 3. Confirmed hepatocellular carcinoma based on CNLC guidelines; 4. Without extrahepatic metastases, unresectable or refuse surgical resection; 5. At least one well defined tumor (mRECIST 1.1); 6. Tumor burden≤50% of the total liver volume; 7. Child-Pugh score≤7; 8. 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; 9. 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. Exclusion Criteria: 1. With previous history of hepatic encephalopathy; 2. Extrahepatic disease or combined with other malignant tumors; 3. Infiltrative hepatocellular carcinoma ; 4. With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy; 5. With hepatic artery malformation and unable to undergo TACE or SIRT; 6. Allergy to contrast agents or anesthetics 7. With clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis, or moderate-to-severe esophageal/gastric varices; 8. 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); 9. The single lung radiation absorbed dose\>30 Gy; 10. Tumor thrombus in main portal vein or hepatic artery or hepatic vein or bile duct; 11. Serious infections in active stage or need systematic treatment; 12. Pregnant and lactating women; 13. With positive results of HIV antibody test; 14. HBV DNA or HCV RNA positive; 15. With active syphilis or tuberculosis; 16. 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.

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