Early Hepatocellular Carcinoma study: Therapies
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 study is testing whether SABR can keep early liver cancer from growing for longer than current heat‑probe or blood‑stream treatments. It also looks at how long patients stay cancer‑free, overall survival, side effects, and quality of life.
- Who it's for
- You may be able to join if you have early stage liver cancer and are eligible for one of the treatment options in the study.
- What's involved
- You would receive either SABR radiotherapy or one of the standard treatments like heat probes, chemo, or blood‑stream injections. You will have regular check‑ups and tests to monitor your cancer and side effects.
- Time commitment
- The study lasts about two years, with visits and tests scheduled throughout that time.
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).
- 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...
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).
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Waratah, Australia; Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.