Second Affiliated Hospital of Guangzhou Medical University
Phase
Not applicable
Started
2023-08-10
Last updated
2023-09-14
Condition(s) studied
Hepatocellular Carcinoma
Investigational drug(s) / intervention(s)
SIRT
SIRT: The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Success rate of conversion to resection — 3 years The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
More Second Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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