A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HCC (The SOCRATES HCC Study)

Trans Tasman Radiation Oncology Group (T/A TROG Cancer Research)0 个研究点目标入组 218 人开始时间: 2021年10月25日最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•Inclusion Criteria:
•1)Histological or radiological diagnosis of single, new HCC with largest diameter =8 cm (BCLC stage 0 or A).
•a)If prior history of HCC, the prior HCC must have been:
•-Early stage, solitary HCC, =5 cm in size and,
•-Have arisen within a different liver segment to the current HCC and,
•-Treated with curative intent therapy >2 years prior with no evidence of activedisease at the site.
•2)As per local multidisciplinary HCC meeting consensus patient is suitable for percutaneous thermal ablation and/or transarterial therapies and not suitable for or declined liver resection and not planned for liver transplantation.
•3)Child-Pugh score =B7* with no or diuretic-controlled ascites
•4)ECOG performance status =2
•5)Platelets =50x109/L, Haemoglobin =80 g/L, Neutrophils =1.0x109/L, INR <1.8 (except if on therapeutic anticoagulation)
•6)18 years of age or older and able to provide written consent

•1)Presence of multifocal HCC, macrovascular invasion or extrahepatic disease
•2)Prior treatment for any HCC within last 2 years.
•3)Clinically evident ascites or hepatic encephalopathy
•4)Prior abdominal radiation therapy that would preclude the delivery of protocol defined SABR to the tumour.
•5)Untreated Hepatitis B or C
•6)Known additional invasive malignancy (excluding non-melanoma skin cancer) that is progressing or required treatment within the last 2 years.
•7)Pregnancy

发起方

Trans Tasman Radiation Oncology Group (T/A TROG Cancer Research)