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

Phase 2

Recruiting

• Conditions: Early Hepatocellular Carcinoma; Cancer - Liver

• Registration Number: ACTRN12621001444875
• Lead Sponsor: Trans Tasman Radiation Oncology Group (T/A TROG Cancer Research)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-25
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate 2 year freedom from local progression (FFLP) based on MRI or CT scans for SABR versus thermal ablation in Cohort 1 and SABR versus standard of care (transarterial therapies and/or thermal ablation) in Cohort 2.[ 2 years post commencement of treatment]