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RecruitingLast updated: 4 December 2024

SOCRATES HCC: This study is investigating whether a radiation therapy technique called SABR can improve outcomes for people with early stage liver cancer compared to other current treatmentsA randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HCC

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

SOCRATES HCC

Clinical summary

Summary

Currently, what treatment people with early stage liver cancer are offered varies in individual circumstances but can include:

  • Radiofrequency ablation (RFA) or microwave ablation (MWA) techniques that use heating probes directly inserted into the tumour to kill the ancer cells.
  • Transarterial chemoembolisation (TACE) or transarterial radioembolisation (TARE) that uses chemotherapy or radioactive particles injected into the blood supply of the tumour to kill the cancer cells.
  • Stereotactic Ablative Body Radiotherapy (SABR) is a highly precise radiation therapy technique that uses high energy x-rays focused on the tumour to kill the cancer cells.

About this study

This study is recruiting people with primary hepatocellular carcinoma (HCC) who have not yet received any prior treatment for this.

Participants in the study will be randomly allocated to one of two treatment groups.

Group 1: Participants will receive radiation therapy using the SABR technique which will be delivered in 3 or 5 outpatient treatment sessions (each 20-45 minutes in duration) spaced out over 1-2 weeks. The exact number of treatment sessions received, and the duration of each session depends on the size and location of the liver cancer.

Group 2: Participants will receive standard of care treatment as per their institution's local practice that will be administered by a doctor called an Interventional Radiologist. The therapies offered will depend on the size and location of the liver cancer and may include one or a combination of RFA/MWA and/or TACE/TARE. This may require an anaesthetic and an overnight admission to the hospital.

Regular follow-up visits will be scheduled at 4 weeks post-treatment and then 3-monthly intervals for 2 years, and then 6 monthly until the completion of the trial. The same procedures will be repeated but also include iamging: CT or MRI of the liver, blood tests, clinical assessments and a questionnaire on the patient's health status (collected 6 monthly until completion of the trial).

Conditions

This trial is treating people with liver cancer who haven't had any treatment yet

Eligibility

Inclusion

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

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

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

Trans Tasman Radiation Oncology Group

Scientific Title

A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HCC

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