A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1003 in Combination with Lenvatinib Compared to Placebo in Combination with Lenvatinib as First-Line Therapy in Subjects with Advanced Hepatocellular Carcinoma (HCC)
This research study is about a type of advanced liver cancer (hepatocellular carcinoma) that can't be treated with surgery. Doctors are testing a new medicine called CS1003, alongside a treatment that's already used, Lenvatinib. Some people will get CS1003 plus Lenvatinib, while others will get Lenvatinib plus a dummy medicine (placebo). This is to find out if adding CS1003 helps people with this cancer live longer. They will also look at how many people respond to the treatment. This is a "Phase III" study, which means it's a final step to see if the new treatment is safe and works better than current options.
At a glance
What is this study about?
This study is for adults who have advanced liver cancer, specifically a type called hepatocellular carcinoma (HCC), where surgery is not an option. Doctors are always looking for better ways to treat cancer, and this study explores whether a new drug, CS1003, can improve outcomes when given with an existing treatment, Lenvatinib.
Lenvatinib is already used to treat people with this type of liver cancer. In this study, some people will receive Lenvatinib along with the new drug, CS1003. Others will receive Lenvatinib with a "placebo," which looks exactly like CS1003 but doesn't contain any active medicine. This helps researchers fairly compare the new drug's effects. Neither you nor your doctor will know whether you are receiving CS1003 or the placebo during the study.
The main goal of this research is to see if adding CS1003 to Lenvatinib helps people live longer than Lenvatinib alone. The researchers will also look at how often the cancer shrinks or stops growing (what they call "objective response rate"). This information is crucial for understanding if CS1003 could become a new treatment option for advanced liver cancer.
Key takeaways
- This study is for advanced liver cancer that cannot be surgically removed.
- It tests a new drug (CS1003) with an existing one (Lenvatinib).
- The main goal is to see if the new combination helps people live longer.
- Participation involves regular hospital visits for checks and medication.
- You won't know if you're getting the new drug or a dummy drug alongside Lenvatinib.
- You can stop participating at any time.
Who may be eligible?
To be able to take part in this study, you generally need to be an adult, 18 years old or older. The study welcomes both men and women.
Your doctor will check if you have advanced hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery. They will also make sure your overall health is good enough to participate and that you meet other specific medical requirements for the study.
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?
- Do you have a type of advanced liver cancer called hepatocellular carcinoma?
- Has your doctor told you that your cancer cannot be removed by surgery?
- Are you able to take medicines by mouth?
- Are you generally in good enough health to consider a new treatment?
What does participation involve?
If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to one of two groups. One group will receive the new drug CS1003 plus Lenvatinib, and the other will receive a dummy drug (placebo) plus Lenvatinib. Both CS1003/placebo and Lenvatinib are taken as medications.
You will have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how your cancer is responding. These visits will likely be more frequent at the start and then may become less often. The study will continue for as long as the treatment is helping and safe for you, and you'll have follow-up appointments even after stopping the study medication to track your health. The total duration of your participation will depend on how you respond to the treatment and the study's follow-up plan, but it could last for many months to a few years.
Potential risks and benefits
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Common questions
What is hepatocellular carcinoma?
It's the most common type of liver cancer that starts in the liver cells.
What is a 'placebo'?
A placebo is a dummy pill or treatment that looks like the real drug but contains no active medicine. It helps compare the new drug's effects properly.
Why is this a 'double-blind' study?
Double-blind means neither you nor your study doctor will know whether you are receiving the new drug or the placebo. This prevents bias in the results.
What does 'first-line therapy' mean?
It means the study drug combination would be the first main treatment you receive for your advanced liver cancer.
Will I get paid for joining the study?
Generally, study participants are not paid for taking part, but some studies may cover travel costs or expenses related to your visits.
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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