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Compares treatment options for Early Hepatocellular Carcinoma
Official title A Study of Standard Of Care Versus Radio Ablation in Early Stage HCC
ClinicalTrials.gov ID: NCT07628751
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Waratah, Australia
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Waratah, Australia; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.