SIRT for Potentially Resectable HCC

Официальное название

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

Обзор

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).

Подробное описание

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).

Вмешательства

• Процедура 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.

Первичные конечные точки

• Success rate of conversion to resection [Срок оценки: 3 years]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT05994859 · MIIR-15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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