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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhongda Hospital, Southeast University
RECRUITING
Nanjing
Contact Information
Primary
Hai-Dong Zhu
zhuhaidong9509@163.com
+86-25-83272121
Backup
Lei Zhang
llei589@126.com
+86-25-83272121
Time Frame
Start Date: 2025-04-03
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 108
Treatments
Experimental: SIRT Group
Each Participant will underwent a single intra-arterial infusion of yttrium-90 carbon microspheres (NRT6003 injection)\].
Active_comparator: cTACE Group
Each Participant will underwent conventional transarterial chemoembolization (cTACE).
Related Therapeutic Areas
Sponsors
Leads: Zhongda Hospital

This content was sourced from clinicaltrials.gov

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