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SIRT for Potentially Resectable HCC
RECRUITINGN/ASponsored by Second Affiliated Hospital of Guangzhou Medical University
Actively Recruiting
PhaseN/A
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Started2023-08-10
Est. completion2026-08-09
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05994859
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
Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria: * 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 Criteria: * 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
Conditions4
CancerHepatocellular CarcinomaLiver CancerLiver Disease
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Actively Recruiting
PhaseN/A
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Started2023-08-10
Est. completion2026-08-09
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05994859