Status:
RECRUITING
SIRT for Potentially Resectable HCC
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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).
Detailed Description
This is a bi-center, prospective study to evaluate the efficacy and safety of SIRT in patient with potentially resectable HCC. 35 patients with potentially resectable (initially unresectable) HCC wil...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Tumor involving main portal vein, bilateral branches of portal vein, or vena cava
- tumor extention beyond one lobe of the liver
- Bilobar tumor distribution
- Extrahepatic metastasis
- Decompensated liver function, including ascites, bleeding from esophageal and gastric varices, and/or hepatic encephalopathy
- Organ (heart, kidney) dysfunction
- HBsAg and anti-HCV antibody positive concurrently
- History of malignancy other than HCC
- Uncontrolled infection
- History of HIV
- History of organ and cell transplantation
- Patients with bleeding tendency
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 9 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05994859
Start Date
August 10 2023
End Date
February 9 2027
Last Update
September 14 2023
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260