Adjuvant chemotherapy with gemcitabine and cisplatin compared to standard of care after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial)
This important study, called ACTICCA-1, is for people who have had surgery to remove certain types of bile duct cancer (cholangiocarcinoma) or gallbladder cancer. These are cancers where the surgeon tries to remove all the cancer they can see. The study wants to find out if giving extra medicine, called chemotherapy, after surgery helps prevent the cancer from coming back. They are comparing a standard chemotherapy treatment to a new combination of medicines (gemcitabine and cisplatin). Researchers will look at how long people stay cancer-free, how long they live, how treatment affects their daily life and any side effects. The goal is to improve future care for these cancers.
At a glance
What is this study about?
Imagine you've had surgery to remove a type of cancer, either from your bile ducts or your gallbladder. These are tubes that help your body digest food. Even after a successful surgery where doctors remove all the visible cancer, there's a small chance some tiny cancer cells might be left behind, too small to see. These cells could cause the cancer to come back later.
This study, called ACTICCA-1, is designed to see if giving extra medicine after surgery, known as 'adjuvant chemotherapy', can help prevent the cancer from returning. It's like an extra step to try and make sure the cancer stays away. The study is comparing two different chemotherapy treatments: one that is typically given (which includes a medicine called capecitabine) and a new combination of medicines (gemcitabine and cisplatin). The aim is to find out which approach is better at keeping the cancer from coming back.
The researchers will closely watch how participants are doing over time. They will check things like how long people stay cancer-free, their overall health, how the treatment affects their daily life and any side effects they might experience. By comparing these outcomes between the two treatment groups, they hope to learn which treatment is more effective and tolerable, ultimately improving the care for people with these specific types of cancer in the future.
Key takeaways
- It's for specific bile duct or gallbladder cancers after surgery.
- Compares standard chemotherapy to a new combination (gemcitabine and cisplatin).
- Aims to prevent cancer from coming back.
- Will assess how long people stay cancer-free, overall survival, and quality of life.
- Participation involves regular hospital visits, tests, and follow-up for several years.
- Patients aged 18+ whose cancer has been surgically removed and has not spread are eligible.
Who may be eligible?
This study is looking for adults who have recently had surgery. The surgery must have been to completely remove certain types of cancer from their bile ducts (these types are called intrahepatic, hilar, or distal cholangiocarcinoma) or a type of gallbladder cancer that has grown into the muscle (muscle invasive gallbladder carcinoma).
It's very important that after your surgery, doctors have not found any signs that the cancer has spread to other parts of your body. Your doctors would need to confirm that they believe all visible cancer was removed during the operation.
You need to be at least 18 years old to join this study, and people of any age above 18, and any gender, can take part if they meet the specific medical requirements for their cancer type and surgery.
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.
- I am at least 18 years old.
- I have had surgery to remove a bile duct cancer (cholangiocarcinoma) or a muscle-invasive gallbladder cancer.
- My doctors believe they removed all visible cancer during surgery.
- Scans and tests show that my cancer has not spread to other parts of my body.
What does participation involve?
If you join this study, you'll be given either the standard chemotherapy treatment or a newer combination, like tossing a coin to decide. You will have regular appointments with the study team. These visits will involve blood tests, check-ups to see how you're feeling, and discussions about any side effects you might be having. You'll also complete questionnaires about your quality of life to see how the treatment affects your daily activities and well-being.
After you finish your chemotherapy, the study will continue to follow your health over several years. This follow-up will involve regular scans and doctor visits to check if the cancer has returned. The whole process, from beginning treatment to the final follow-up checks, will take several years, but the active treatment part is much shorter.
Potential risks and benefits
Locations (4)
- —UnverifiedAustria
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedNetherlands
Common questions
What is 'adjuvant chemotherapy'?
It's extra medicine given after surgery to try and kill any tiny cancer cells that might have been left behind, even if they can't be seen.
What does 'Phase III' mean for a trial?
Phase III means this study is comparing a new treatment or approach to the best existing treatment. It's usually the final step before a new treatment might become widely available.
Will I know which treatment I'm getting?
In this study, which specific chemotherapy you get would be decided randomly, like drawing lots. You will know if you are getting the standard treatment or the new combination.
What does 'cholangiocarcinoma' mean?
It's a type of cancer that starts in the bile ducts, which are tubes that carry digestive fluid from your liver and gallbladder.
How long will I be involved in this study?
The active treatment period is usually several months, but the full follow-up to check your health will last for several years.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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