A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)
This study, called FIGHT-302, is for people with bile duct cancer (cholangiocarcinoma) that has spread or can't be surgically removed, and has a particular gene change called an FGFR2 rearrangement. The main goal is to compare a new drug, pemigatinib (taken as tablets), with standard chemotherapy (gemcitabine and cisplatin, given through a drip). Researchers want to find out if pemigatinib is more effective at slowing down or stopping the cancer from growing, and if it's generally safer than the usual treatment. This is a Phase 3 study, meaning it's in the final stages of testing, aiming to confirm whether the new drug is a good option for treating this cancer first. Participants will be randomly assigned to receive either the new drug or the standard chemotherapy.
Em resumo
Sobre o que é este estudo?
This study is looking into a type of cancer that starts in the bile ducts, called cholangiocarcinoma. For some people, this cancer has unfortunately spread to other parts of the body or can't be removed with surgery. This particular study is for people whose cancer also has a specific change in its genes, called an FGFR2 rearrangement. This genetic change can sometimes make the cancer respond differently to treatments.
The main aim of this study is to compare two different ways of treating this cancer. One is the standard treatment, which is a combination of two chemotherapy drugs, gemcitabine and cisplatin, given through a drip. The other is a newer drug called pemigatinib, which you would take as tablets. Researchers want to see if pemigatinib works better at controlling the cancer and if it has fewer or different side effects compared to the standard chemotherapy.
This is a 'Phase 3' study, which means it's a big, important step in testing new treatments. The results will help doctors understand which treatment might be the best first choice for people with this specific type of bile duct cancer, helping them live longer and have a better quality of life.
Pontos principais
- This study compares a new drug (pemigatinib) to standard chemotherapy for bile duct cancer.
- It's for people with advanced cholangiocarcinoma and a specific gene change (FGFR2 rearrangement).
- It's a 'Phase 3' study, aimed at finding the best first treatment option.
- Participation involves regular hospital visits, tests, and taking either tablets or having infusions.
- You'll be closely monitored for cancer changes and side effects.
Quem pode ser elegível?
To be considered for this study, you must be at least 18 years old. Both men and women can take part.
You would need to have cholangiocarcinoma (bile duct cancer) that can't be removed by surgery or has spread to other parts of your body. Importantly, your cancer must also have a specific gene change, called an FGFR2 rearrangement.
The study team will check other health details to make sure the treatment is safe for you. They will review all your medical information carefully to see if you are a good fit for this important research.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem 18 anos ou mais?
- Do you have bile duct cancer (cholangiocarcinoma)?
- Has your cancer spread, or can it not be removed by surgery?
- Has your doctor told you that your cancer has an 'FGFR2 rearrangement' gene change?
O que envolve a participação?
If you join this study, you will be randomly placed into one of two groups, like flipping a coin. One group will receive the new drug, pemigatinib, which you take as tablets. The other group will receive standard chemotherapy with gemcitabine and cisplatin, given through an injection into a vein. You won't get to choose which treatment group you are in, but everyone in the study will get one of the active treatments.
You will have regular hospital visits for check-ups, blood tests, scans, and to get your medication. These visits will help the doctors monitor how you are doing, how the treatment is affecting your cancer, and to check for any side effects. You will also be asked to fill out questionnaires about how you are feeling and your quality of life during the study. The total duration of your participation, including follow-up after treatment, will be discussed by the study team.
Riscos e benefícios potenciais
Locations (8)
- —Não verificadoAlemanha
- —Não verificadoBélgica
- —Não verificadoItália
- —Não verificadoEspanha
- —Não verificadoPaíses Baixos
- —Não verificadoSuécia
- —Não verificadoÁustria
- —Não verificadoFrança
Perguntas frequentes
What is cholangiocarcinoma?
Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are tubes that carry bile from the liver.
What is an FGFR2 rearrangement?
This is a specific change in the genes within the cancer cells. It's important because some treatments are designed to target these specific changes.
What does a 'Phase 3' study mean?
Phase 3 means this is a large study comparing a new treatment to a standard treatment to see which is better and safer. It's usually the last step before a new drug might become widely available.
Will I know if I'm getting the new drug or chemotherapy?
Yes, this is an 'open-label' study, which means both you and your doctors will know which treatment you are receiving.
Quanto tempo estarei no estudo?
The exact length of time you'll be in the study will depend on how your body responds to the treatment and your individual situation. The study team will explain this in more detail.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Interessado em participar?
Discussão
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