All studies
Active not recruitingPHASE3INTERVENTIONAL

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

Status
Active not recruiting
Phase
PHASE3
Sponsor
Exelixis
Enrolment target
837
Start
10 Jun 2018
Estimated completion
31 Jul 2026

Results

Results from this study

Posted December 2025

Results have been published for this study.

Primary outcome
Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population
PFS was defined as the time from randomization to the earlier of either the date of radiographic progression defined as a 20% increase in the sum of the longest diameters of target lesions, or the unequivocal appearance of new lesions, or progression of non-target disease per Blinded Independent Radiology Committee (BIRC) or the date of death due to any cause per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Full results on the registry

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.

  1. Do I have a confirmed diagnosis of advanced liver cancer?
  2. Has my liver cancer not been treated with drugs before?
  3. Is my liver cancer too advanced for surgery or local treatments like transplants?
  4. Are my general health and liver function good enough, as assessed by doctors?
  5. Do I have any specific rare types of liver cancer that would exclude me?
  6. Have I had recent radiation therapy or unmanaged brain metastases?
Answer every question to see your result.

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

Taking part in any medical study has potential benefits and risks. You might benefit from a new treatment that could be more effective than standard care, but there's no guarantee the treatment will work for you. There is also a risk of experiencing side effects from the study drugs, which your medical team will monitor closely. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (245)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Exelixis Clinical Site #208
    Verified postcode
    Phoenix, United States
  • Exelixis Clinical Site #159
    Verified postcode
    Tucson, United States
  • Exelixis Clinical Site #44
    Verified postcode
    La Jolla, United States
  • Exelixis Clinical Site #112
    Verified postcode
    Los Angeles, United States
  • Exelixis Clinical Site #200
    Verified postcode
    Orange, United States
  • Exelixis Clinical Site #2
    Verified postcode
    Rialto, United States
  • Exelixis Clinical Site #207
    Verified postcode
    San Diego, United States
  • Exelixis Clinical Site #109
    Verified postcode
    San Francisco, United States
  • Exelixis Clinical Site #54
    Verified postcode
    San Francisco, United States
  • Exelixis Clinical Site #58
    Verified postcode
    Washington D.C., United States
  • Exelixis Clinical Site #191
    Verified postcode
    Miami, United States
  • Exelixis Clinical Site #4
    Verified postcode
    Atlanta, 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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