A Study of Standard Of Care Versus Radio Ablation in Early Stage HCC

Official title

A Randomized Controlled Trial of Standard Of Care Versus Radio Ablation in Early Stage Hepatocellular Carcinoma

Overview

This Phase II Prospective, parallel and open-label randomised control trial will investigate whether a radiotherapy technique (called SABR) can treat early stage liver cancer more effectively than current treatments which use heating probes directly inserted into the tumour or chemotherapy or radioactive particles injected into the blood supply of the tumour. Investigators hypothesize SABR will result in higher rates of freedom from local progression (FFLP) at 2 years compared to percutaneous thermal ablation ± TACE or transarterial therapies (TACE/TARE).The study will also look at other important outcomes such as progression free survival, overall survival, side effects, quality of life and people's experiences of their treatment.

Detailed description

The SOCRATES randomised controlled trial will assess the efficacy, toxicity, HRQoL profile and cost effectiveness of SABR compared to the current SOC treatment in patients with first diagnosis of unresectable, single nodule HCC. Participants will be placed into one of two groups based on the size of their tumour and whether thermal ablation is an appropriate treatment for them. The study will include about 218 participants in total. Participants will be randomly assigned to receive either SABR or the current standard of care. Standard care may include thermal ablation, transarterial chemoembolisation (TACE), or transarterial radioembolisation (TARE).

Interventions

• Radiation Stereotactic Ablative Body Radiotherapy (SABR)
  SABR will be delivered in 3 or 5 outpatient treatment sessions (each 20 to 45 minutes in duration) spaced out over 1 to 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.
• Radiation Therapies
  Patients will receive standard of care treatment (SOC) 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 radiofrequency ablation (RFA) / microwave ablation (MWA) and/or transarterial chemoembolization (TACE) / transarterial radioembolisation (TARE).

Primary outcome measures

• Freedom from local progression (FFLP) [Time frame: 2 years]

Secondary outcome measures (6)

• Progression-free survival (PFS) [Time frame: 2 years]
• Overall survival (OS) [Time frame: 2 years]
• Safety and adverse events (CTCAE v5.0) [Time frame: 2 Years]
• Patient reported outcomes (EORTC QLQ-C30) [Time frame: 2 Years]
• Patient reported outcomes (QLQ-HCC18) [Time frame: 2 Years]
• Cost-effectiveness analysis [Time frame: 2 Years]

Eligibility 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 active disease 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Australia · 1 center

• Trans Tasman Radiation Oncology Group — Waratah

Canada · 1 center

• University Health Network - Princess Margaret Cancer Centre — Toronto

Identifiers

NCT: NCT07628751 · 25-5862 · ACTRN12621001444875

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗