HEpatocellular carcinoma stereotactic RAdiotherapy CLinical Evaluation Study - HERACLES

niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde0 个研究点目标入组 75 人开始时间: 2016年3月10日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Histologically or cytologically confirmed hepatocellular carcinoma OR diagnosis made with characteristic enhancement in 4-Phase CT or MRI corresponding to AASLD- / EASL guidelines in cirrhotic patients; Discussion in a routine multidisciplinary tumour board; Understanding of procedure, significance and consequences of the study; given informed consent. SBRT Group: Patients unsuitable for surgery, TACE*, RFA, or alcohol ablation / *TACE patients will be recruited for control group; bilirubin has to be < 4 x the upper limit of normal, AST or ALT < 6 x the upper limit of normal, international normalized ratio < 1.5 except if patients are on oral anticoagulation, haemoglobin= 90 g/L, platelets = 50 x 10^9/L, and neutrophils = 1.0 x 10^9/L. TACE Group: Patients suitable for TACE; bilirubin has to be <2 mg/dL, AST or ALT < 6 x the upper limit of normal, international normalized ratio < 1.5 except if patients are on oral anticoagulation, haemoglobin= 90 g/L, platelets = 50 x 10^9/L, and neutrophils = 1.0 x 10^9/

•Child-Turcotte-Pugh (CTP) C liver score; Hepatic encephalopathy more than Grade 1 according to Child Pugh criteria; Active hepatitis; Gastric, duodenal or variceal bleed within 2 months of registration; Prior radiotherapy of the region to be treated; For female patients: Pregnancy, planned pregnancy

发起方

niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde