SIRT Versus cTACE for Unresectable HCC (CHANCE2506)

Launched by ZHONGDA HOSPITAL · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial, called CHANCE2506, is studying two different treatments for patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be surgically removed. The trial will compare Yttrium-90 carbon microspheres, a type of targeted radiation therapy, with conventional transarterial chemoembolization (cTACE), which delivers chemotherapy directly to the tumor. The goal is to see which treatment is more effective and safer for patients with this condition.

To participate, patients need to be between the ages of 65 and 74, have a confirmed diagnosis of HCC, and have a life expectancy of at least three months. They should not have cancer that has spread outside the liver and must have well-defined tumors that make up less than half of their liver volume. Participants will receive regular check-ups and monitoring throughout the study to ensure their safety and track the effectiveness of the treatments. It's important for potential participants to meet specific health criteria and to be willing to use contraception if they are of childbearing age. Overall, this trial aims to find better treatment options for patients facing this challenging diagnosis.

Gender

ALL

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.