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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

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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