Strategy Option in Combined locoregional treatment (Strategy CHemoEMbolization & Ablation) of patients with hepatocellular carcinoma: A Non-inferiority Randomized Multicenter Trial - SCHEMA

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 160 人开始时间: 2021年5月24日最近更新: 2023年8月21日

适应症

试验速览

暂无简介。

•Patients older than 18 years of age
•Uninodular or multinodular (maximum 3 nodules) HCC with target lesion(s) = 3 cm and < 7 cm in size, not suitable for surgery
•Unilobar Disease
•Adequate information and subsequent written informed consent
•Tumor volume = 50% of liver volume
•Liver cirrhosis classified as Child-Pugh score A or B7
•normalized ratio (INR) < 1.5; if a patient was on anticoagulants, they had to be able to stop medication temporarily prior to transarterial chemoembolization and have INR < 1.5 at the time of the procedure
•Adequate liver function, defined by total bilirubin < 2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase was more than five times upper limit of normal range, and albumin > 2.5 g/dl
•Adequate renal function, defined by serum creatinine < 2.0 mg/dl
•No confirmed extrahepatic metastases, except for limited extra-hepatic spread defined as portal or mesenteric lymph nodes at imaging up to 2.5 cm each based on measurement of the short axis, focal lung lesion single < 1.5 cm or multiple lesions for a total diameter < 2 cm
•Performance status (ECOG) classified as 0-1 category
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 64
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 96

•Known hypersensitivity reactions towards components of the study drugs
•Child-Pugh score > B7
•Performance status (ECOG) = 2,
•Macrovascular invasion, only if assessed on pre-procedural imaging
•Platelet count < 40,000/µL and/or international normalized ratio >1.5,
•Severe renal impairment or serum creatinine levels = 2 mg/dl
•Family, psychological, social or geographical circumstances preventing the patients from undergoing follow-up and from complying with protocol procedures

发起方

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE