Efficacy and safety of Cabozantinib in patients with hepatocellular carcinoma progressing on or intolerant to prior treatment with immune checkpoint inhibitors: A phase II study (Immunocabo)
This study is investigating a medicine called cabozantinib for liver cancer, specifically hepatocellular carcinoma. It's for patients whose cancer has either continued to grow or who couldn't tolerate their previous treatments that involved what are called immune checkpoint inhibitors. Researchers want to find out how effective cabozantinib is at controlling the cancer's growth and how safe it is for patients to take. Participants would take cabozantinib as tablets. This is a Phase II study, which means it’s looking closely at how well the new treatment works and its side effects after early safety tests have been done. The main goal is to see how long patients live without their cancer getting worse.
At a glance
What is this study about?
This study, called Immunocabo, is focused on improving treatment for a type of liver cancer known as hepatocellular carcinoma. This is the most common form of liver cancer. We know that cancer treatments are constantly evolving, and sometimes a treatment that works for a while might eventually stop being effective or cause too many side effects.
This particular study is for patients whose liver cancer has not responded well to, or who could not tolerate, their previous treatments. The researchers are testing a drug called cabozantinib, which is given as a tablet. They want to understand if cabozantinib can help stop the cancer from growing for longer and how this new treatment affects patients' overall health and well-being. It's important to find new options for people when standard treatments aren't enough.
The main thing the study will measure is how long patients can take cabozantinib before their cancer starts to grow again or gets worse. They will also look at how many people see their cancer shrink or stop growing, how long these improvements last, and how safe the treatment is by keeping a close eye on any side effects.
Key takeaways
- This study is for people with liver cancer (hepatocellular carcinoma).
- It tests a drug called cabozantinib for patients who haven't responded to previous treatments.
- The main aim is to see how well cabozantinib stops cancer growth.
- Participants take cabozantinib as tablets and have regular check-ups.
- It's a Phase II study, focusing on how well the treatment works and its safety.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years of age or older. This study is open to both men and women.
The most important requirement is that you have hepatocellular carcinoma, which is a type of liver cancer. Also, your cancer must have either continued to get worse despite previous treatments, or you couldn’t continue with those treatments because of difficult side effects.
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.
- Are you 18 years old or older?
- Have you been diagnosed with hepatocellular carcinoma (liver cancer)?
- Has your liver cancer gotten worse, or could you not tolerate your previous cancer treatments?
- Are you willing to take medication in tablet form?
- Are you able to attend regular hospital visits for check-ups and tests?
What does participation involve?
If you decide to take part in this study, you will be given cabozantinib tablets to take. The dose of the tablets might be 60 mg, 40 mg, or 20 mg, and the study doctors will decide which is best for you. The study team will closely monitor your health throughout.
You will have regular hospital visits for check-ups, tests, and to make sure the medicine is working and that you are not experiencing too many side effects. These visits will likely involve blood tests, scans (like CT or MRI) to check on your cancer, and discussions with the study doctors and nurses. The total length of your participation will depend on how you respond to the treatment and the study's monitoring schedule, but it will involve continued follow-up for a period after you stop taking the treatment.
Potential risks and benefits
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Common questions
What is hepatocellular carcinoma?
It's the most common type of primary liver cancer, meaning it starts in the liver itself.
What does a 'Phase II study' mean?
It means the study is looking closely at how well the new treatment works and its side effects, after early safety tests have been done.
What is cabozantinib?
It's a medicine given as a tablet that the study is testing to treat liver cancer when previous treatments have not been successful.
Will I know if I'm getting the active drug?
In this specific study, all participants who receive treatment will be taking cabozantinib.
Can I stop taking part if I change my mind?
Yes, you can leave the study at any time, and it won't affect your regular medical care.
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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