Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial

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

This study is conducted to evaluate the efficacy and safety of Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• HCC with diagnosis confirmed pathologically or clinically

• No pervious treatment for HCC

• At least one measurable intrahepatic target lesion

• Potentially resectable HCC: tumor(s) confined to the left/right hemiliver, with/without invasion to the unilateral branch of the portal vein and/or hepatic vein

• Disease amenable to SIRT (after evaluation)

• Child-Pugh Class A or without cirrhosis

• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1

• Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL

• Patients with hepatitis C need to finish the anti-HCV treatment

• Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10\^9/L, white blood cell count \>3.0×10\^9/L, absolute value of neutrophils \>1.5×10\^9/L, hemoglobin ≥85 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range

• Life expectancy of at least 6 months

Locations
Other Locations
China
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Mingyue Cai, Dr.
cai020@yeah.net
+86-20-34156205
Backup
Kangshun Zhu, Dr.
zhksh010@163.com
+86-20-34156205
Time Frame
Start Date: 2023-08-10
Estimated Completion Date: 2027-02-09
Participants
Target number of participants: 35
Treatments
Experimental: SIRT
Treatment with SIRT.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital of Guangzhou Medical University

This content was sourced from clinicaltrials.gov

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