RECRUITINGINTERVENTIONAL
SIRT for Potentially Resectable HCC
Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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, blood count (hemoglobin) at least 85 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range
- expected to live at least 6 months
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
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.
Locations (1)
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China