Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy
This study is for adults with a type of advanced liver cancer (hepatocellular carcinoma) who haven't had previous treatment for it. It's a Phase 3 trial, which means it's testing new drug combinations against a standard treatment that's already used. Researchers want to see if combining two drugs, cabozantinib and atezolizumab, is safer and more effective than sorafenib alone. There will also be a group receiving only cabozantinib to understand its role. The main goal is to find out if these new treatments can help people live longer and prevent the cancer from growing for a longer time. This research is important for finding better ways to treat this type of cancer.
At a glance
Results
Results from this study
Posted December 2025Results have been published for this study.
What is this study about?
This important study is designed for adults who have a type of advanced liver cancer called hepatocellular carcinoma, and who haven't had any drug-based treatments for it yet. Doctors are always looking for better ways to treat cancer, and this study is testing whether a combination of two drugs, cabozantinib and atezolizumab, could be more effective and safer than a standard treatment called sorafenib.
Think of it like this: sorafenib is already a known treatment for this cancer, but doctors want to see if a newer approach can improve things further. The study will look closely at how long people live and how long it takes before their cancer starts to grow again. There will also be a small group of people who receive just cabozantinib so doctors can understand how much each drug contributes to the overall effect.
Finding new and better treatments for advanced liver cancer is crucial. This study aims to provide clear answers on whether these new combinations offer a real advantage for patients. Your participation could help improve care for many others in the future.
Key takeaways
- This study evaluates new drug combinations for advanced liver cancer.
- It compares new treatments against a standard care drug, sorafenib.
- The main goals are to improve how long people live and prevent cancer growth.
- Participants must have advanced liver cancer and no prior drug therapy for it.
- Regular clinic visits, blood tests, and scans will be part of the study.
- You can leave the study at any time without affecting your medical care.
Who may be eligible?
This study is designed for adults with advanced liver cancer (hepatocellular carcinoma) that has been diagnosed by medical tests. Your cancer shouldn't be treatable by surgery, transplant, or other local treatments. You must also not have had any previous drug treatments for your advanced liver cancer.
There are also some specific medical requirements, such as how well your liver is working and your general health. For example, your liver function needs to be good enough, and you should be generally active. Your cancer also needs to be measurable, meaning doctors can see and track its size.
However, you cannot join if you have a different rare type of liver cancer, or if your cancer has spread to your brain unless it's been successfully treated and stable for several weeks. You also can't be on certain blood thinners or have had recent radiation therapy.
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.
- Do I have a confirmed diagnosis of advanced liver cancer?
- Has my liver cancer not been treated with drugs before?
- Is my liver cancer too advanced for surgery or local treatments like transplants?
- Are my general health and liver function good enough, as assessed by doctors?
- Do I have any specific rare types of liver cancer that would exclude me?
- Have I had recent radiation therapy or unmanaged brain metastases?
What does participation involve?
If you decide to join this study, you will first go through an initial screening to ensure you meet all the requirements. If you do, you'll be assigned randomly to one of three groups: one group will receive a combination of cabozantinib and atezolizumab, another will receive sorafenib, and a third will receive only cabozantinib. You won't be able to choose which group you are in, and neither you nor your doctor will know which treatment you are receiving (this is called 'open-label' for the first two groups, but you'll know if you're in the cabozantinib-only arm).
Both drugs are taken orally, likely as tablets or capsules, and atezolizumab is given as an infusion. You'll have regular visits to the clinic for medical check-ups, blood tests, and scans (like CT or MRI) to see how you're responding to the treatment and to monitor for any side effects. The treatment will continue for as long as it's helping and you're not having serious side effects. After treatment stops, there will be follow-up appointments to track your health and gather more information, which could last for several months or longer.
Potential risks and benefits
Locations (245)
- Exelixis Clinical Site #208Verified postcodePhoenix, United States
- Exelixis Clinical Site #159Verified postcodeTucson, United States
- Exelixis Clinical Site #44Verified postcodeLa Jolla, United States
- Exelixis Clinical Site #112Verified postcodeLos Angeles, United States
- Exelixis Clinical Site #200Verified postcodeOrange, United States
- Exelixis Clinical Site #2Verified postcodeRialto, United States
- Exelixis Clinical Site #207Verified postcodeSan Diego, United States
- Exelixis Clinical Site #109Verified postcodeSan Francisco, United States
- Exelixis Clinical Site #54Verified postcodeSan Francisco, United States
- Exelixis Clinical Site #58Verified postcodeWashington D.C., United States
- Exelixis Clinical Site #191Verified postcodeMiami, United States
- Exelixis Clinical Site #4Verified postcodeAtlanta, United States
Common questions
What is advanced hepatocellular carcinoma?
It's a type of liver cancer that has grown or spread beyond the liver and can no longer be cured by surgery or other local treatments.
What are cabozantinib, atezolizumab, and sorafenib?
These are all medicines used to treat cancer. Cabozantinib and sorafenib are tablets that help stop cancer growth, while atezolizumab is given by drip and works with your body's immune system to fight cancer.
What does 'Phase 3 study' mean?
It means this is one of the final stages of testing a new treatment. It compares it against existing standard treatments to see if it's better or safer, typically involving many patients.
Will I know which treatment I am getting?
In this specific study, neither you nor your doctor will know if you're receiving the combination of cabozantinib and atezolizumab or sorafenib. However, if you are in the group receiving only single-agent cabozantinib, you and your doctor will know this.
What if the treatment isn't working for me?
Your doctors will regularly check how you’re responding. If the treatment isn't helping or you have serious side effects, you will stop the study treatment and discuss other options with your medical team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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