SIRT for Potentially Resectable HCC

Official title

Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial

Overview

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 will be enrolled in this study. 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. If the patients are evaluated as resectable during follw-up, liver resection will be recommended.

The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to progression (TTP), duration of response (DOR), overall survival (OS) and adverse events (AEs).

Interventions

• 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.

Primary outcome measures

• Success rate of conversion to resection [Time frame: 3 years]

Secondary outcome measures (7)

• Objective response rate (ORR) [Time frame: 3 years]
• Disease control rate (DCR) [Time frame: 3 years]
• Progression-free survival (PFS) [Time frame: 3 years]
• Time to progression (TTP) [Time frame: 3 years]
• Duration of response (DOR) [Time frame: 3 years]
• Overall survival (OS) [Time frame: 3 years]
• Adverse Events (AEs) [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT05994859 · MIIR-15

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗