A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
This study is testing a new way to prevent primary liver cancer from coming back after surgery or heat treatment (ablation). Even after a tumour has been completely removed or destroyed, there is still a risk that unseen cancer cells remain in the body. Currently in the UK, standard care involves 'active surveillance', which means having regular scans and blood tests to watch for any signs of the cancer returning, without giving extra medicine. This trial compares that usual approach with a combination of two medicines: atezolizumab and bevacizumab. Atezolizumab helps your immune system fight cancer, while bevacizumab blocks the blood supply tumours need to grow. Participants will either receive these two medicines through a drip every three weeks for up to a year, or have standard regular monitoring. Researchers will track both groups to see which approach keeps patients free of cancer for longer.
At a glance
What is this study about?
Primary liver cancer, known as hepatocellular carcinoma, is often treated with surgery to cut out the tumour or with ablation, which uses heat to destroy the cancer cells. While these treatments can completely remove all visible signs of cancer, there is always a chance that microscopic cells remain behind. Over time, these tiny cells can grow and cause the cancer to return. For patients whose tumours were large or showed certain features under a microscope, the risk of recurrence is higher.
At present, the standard NHS approach after successful surgery is called active surveillance. This means you do not take any preventative cancer drugs; instead, your medical team keeps a close eye on you through regular clinic visits, blood tests, and scans. This trial is investigating whether giving preventative treatment straight after surgery—known as adjuvant therapy—can help clear any remaining cells and stop the cancer from returning.
The trial tests a pair of medicines called atezolizumab (Tecentriq) and bevacizumab (Avastin). Atezolizumab is a type of immunotherapy that works by 'unmasking' cancer cells so your body's natural immune system can find and destroy them. Bevacizumab is a targeted therapy that stops tumours from forming new blood vessels to feed themselves. Together, these medicines have already been approved to treat advanced liver cancer, and doctors now want to see if using them earlier can keep patients cancer-free for longer.
Key takeaways
- Tests whether two cancer medicines can stop liver cancer returning after successful surgery or heat treatment.
- Compares the drug combination directly against standard regular hospital monitoring.
- Atezolizumab helps the immune system attack cancer, while bevacizumab stops tumours growing new blood vessels.
- Involves hospital visits every three weeks for up to one year for those in the treatment group.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
To be eligible for this study, you must be 18 years of age or older and have had primary liver cancer that was successfully treated with either surgery or ablation. Because this study focuses specifically on preventing cancer from coming back, your doctor will check whether your original tumour had certain characteristics that put you at a higher risk of recurrence.
You must have had all visible tumour completely cleared, with recent scans confirming that there is no active cancer left in your body before you begin. You also need to have reasonably good liver function and overall health so that you can safely receive the treatments being tested.
You may not be eligible if the cancer has already spread outside your liver, if you have certain active autoimmune conditions, or if you have serious heart or bleeding problems. Your hospital doctor will review your full medical history and scan results to help determine if this trial is suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are aged 18 or over.
- You have recently had surgery or heat treatment (ablation) for primary liver cancer.
- Your post-treatment scans show that all visible cancer was removed or destroyed.
- Your medical team has identified your cancer as having a higher risk of coming back.
- You are in generally good health and able to attend regular hospital appointments.
What does participation involve?
If you decide to join, a computer will assign you by chance (like rolling a die) to one of two groups. One group receives the two study medicines, while the other group receives standard active surveillance. If you are placed in the treatment group, you will receive atezolizumab and bevacizumab as an infusion through a drip in your vein at the hospital once every three weeks. This treatment continues for up to one year, provided you tolerate it well and your cancer does not return. Regardless of which group you are in, you will have regular clinic visits that include blood tests, health checks, and imaging scans (such as CT or MRI scans) to monitor your liver. You will continue to be followed up with routine check-ups for several years so researchers can track your long-term health.
Potential risks and benefits
Locations (9)
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedBelgium
- —UnverifiedAustria
- —UnverifiedNetherlands
- —UnverifiedPoland
Common questions
What is active surveillance?
Active surveillance means having regular doctor check-ups, blood tests, and hospital scans to watch your health closely, without starting drug treatment unless there are signs of cancer returning.
Can I choose to receive the medicines rather than surveillance?
No. A computer assigns participants to a group at random. This is essential to make sure the trial results are fair, accurate, and unbiased.
How often will I need to go to the hospital?
If you are in the treatment group, you will visit the hospital every three weeks for your drip infusions and health checks. Surveillance visits also happen regularly, usually every few months.
What happens if my cancer comes back while on the trial?
If your scans show that the cancer has returned, you will stop the trial treatment and your doctor will immediately discuss the best standard NHS treatment options with you.
Will taking part cost me anything?
No, the trial drugs and all study-related tests are provided free of charge through the hospital clinic.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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