SIRT Versus cTACE for Unresectable HCC (CHANCE2506)
Recruiting now · Not applicable
Conditions studied: Unresectable Hepatocellular Carcinoma
In brief
To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma
Key facts
- Study ID
- NCT06909708
- Run by
- Zhongda Hospital
- People needed
- 108
- Starts
- 2025-04-03
- Expected to finish
- 2027-01-30
- Last updated by the study team
- 2025-04-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- 99mTc-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.
Where it is running
- Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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