Status:
RECRUITING
SIRT Versus cTACE for Unresectable HCC (CHANCE2506)
Lead Sponsor:
Zhongda Hospital
Conditions:
Unresectable Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma
Detailed Description
The efficacy and safety of yttrium-90 carbon microspheres versus in patients with unresectable hepatocellular carcinoma (HCC) remain unknown. This multicenter, prospective, open-label, phase 3 trial i...
Eligibility Criteria
Inclusion
- 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
- 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):
- 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.
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06909708
Start Date
April 3 2025
End Date
January 30 2027
Last Update
April 9 2025
Active Locations (1)
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1
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009