RecruitingNot ApplicableNCT06909708

SIRT Versus cTACE for Unresectable HCC (CHANCE2506)

SIRT (Yttrium-90 Carbon Microspheres) Versus cTACE for Unresectable Hepatocellular Carcinoma: A Multicenter, Prospective, Open-label, Phase 3 Trial (CHANCE2506)

Sponsor

Zhongda Hospital

Enrollment

108 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Unresectable Hepatocellular Carcinoma

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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.

Exclusion Criteria17

With previous history of hepatic encephalopathy;
Extrahepatic disease or combined with other malignant tumors;
Infiltrative hepatocellular carcinoma ;
With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy;
With hepatic artery malformation and unable to undergo TACE or SIRT;
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);
The single lung radiation absorbed dose\>30 Gy;
Tumor thrombus in main portal vein or hepatic artery or hepatic vein or bile duct;
Serious infections in active stage or need systematic treatment;
Pregnant and lactating women;
With positive results of HIV antibody test;
HBV DNA or HCV RNA positive;
With active syphilis or tuberculosis;
mTc-MAA imaging (patients exclusion meet all criteria):
\) 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.