Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma
This research study is investigating a new approach for people who have had surgery and chemotherapy for a type of bile duct cancer called intrahepatic cholangiocarcinoma, specifically if their cancer has a particular genetic change known as an IDH1 mutation. The study is testing whether a drug called ivosidenib, taken after their usual chemotherapy, can help prevent the cancer from returning. Researchers want to find out how effective this treatment is at keeping the cancer away for at least a year, and also how it affects quality of life and if it causes any side effects. This is an early-stage study, meaning it's one of the first times this treatment strategy is being looked at in this specific group of patients, to gather important information for future research.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is designed for individuals who have undergone surgery to remove a type of bile duct cancer called intrahepatic cholangiocarcinoma, and who have also completed standard chemotherapy. A key requirement for joining this study is that your cancer must have a specific genetic change, or 'mutation,' called IDH1. This mutation is like a tiny error in the cancer's genetic code, and the study drug, ivosidenib, is designed to specifically target cells with this IDH1 error.
The main goal is to find out if taking ivosidenib *after* your surgery and chemotherapy can help stop the cancer from coming back. The researchers want to see how many people in the study remain cancer-free a year after starting ivosidenib. They'll also be closely watching to see how well people tolerate the treatment, if it affects their daily lives, and if it improves their overall health over time.
This is a 'Phase II' study, which means it's an earlier stage of research. It's about gathering initial information on how well a new treatment works and if it's safe, often involving a smaller group of people. The information from this study will help doctors understand if ivosidenib could be a valuable new treatment option for people with this specific type of bile duct cancer in the future.
النقاط الرئيسية
- This study evaluates ivosidenib to prevent bile duct cancer recurrence.
- It's for people with a specific genetic change in their cancer (IDH1 mutation).
- Treatment involves taking a pill daily for up to 12 months.
- Regular check-ups and monitoring for safety and effectiveness are part of the study.
- The study aims to see if this treatment keeps the cancer away for at least a year.
- It's an early-stage study to gather important new information.
من قد يكون مؤهلاً؟
You might be able to join this study if you are 18 years or older and have been diagnosed with a specific type of bile duct cancer called intrahepatic cholangiocarcinoma. Importantly, your cancer must have had surgery to remove it completely, and it must have a particular genetic fault known as the IDH1 mutation. You should also have recently finished six months of standard chemotherapy for your cancer, and scans must show you are currently cancer-free.
There are also some health requirements, such as having good general health and normal function of certain organs like your liver, kidneys, and blood. If you are a woman who could become pregnant, or a man with a female partner who could become pregnant, you would need to agree to use effective contraception during and for some time after the study treatment.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك 18 سنة أو أكثر؟
- Do you have intrahepatic cholangiocarcinoma (a type of bile duct cancer)?
- Has your cancer been completely removed by surgery?
- Does your cancer have an 'IDH1 mutation'?
- Have you recently finished 6 months of standard chemotherapy?
- Are your recent scans clear of cancer?
ماذا يتضمن المشاركة؟
If you decide to join this study, you will receive the study drug, ivosidenib, as a pill once a day for up to 12 months. Throughout this time, you will have regular check-ups every 8 weeks, which will likely include scans and other tests to see how you are responding to the treatment and to check for any side effects. After the 12 months of treatment, you will continue to have follow-up appointments every 12 weeks to monitor your health and ensure the cancer has not returned. Overall, your health will be monitored for up to 48 months (4 years) from the time the last person joins the study, or until your enrolment ends for other reasons.
المخاطر والفوائد المحتملة
المواقع (12)
- Uniklinik RWTH Aachenالرمز البريدي المؤكدآخن، ألمانيا· التوظيف
- Universitätsklinikum Bonnالرمز البريدي المؤكدبون، ألمانيا· التوظيف
- Uniklinikum Essenالرمز البريدي المؤكدإيسن، ألمانيا· التوظيف
- Krankenhaus Nordwestالرمز البريدي المؤكدفرانكفورت، ألمانيا· التوظيف
- مستشفى جامعة فرانكفورتالرمز البريدي المؤكدفرانكفورت، ألمانيا· التوظيف
- Universitätsklinik Gießen und Marburg GmbH Standort Gießenالرمز البريدي المؤكدغيسن، ألمانيا· التوظيف
- الطب الجامعي غوتنغنالرمز البريدي المؤكدغوتينغن، ألمانيا· التوظيف
- Uniklinikum Jenaالرمز البريدي المؤكديينا، ألمانيا· التوظيف
- Universitätsmedizin Mainzالرمز البريدي المؤكدماينز، ألمانيا· التوظيف
- Universitätsklinikum Mannheimالرمز البريدي المؤكدمانهايم، ألمانيا· التوظيف
- LMU Klinikum Großhadernالرمز البريدي المؤكدميونخ، ألمانيا· التوظيف
- Klinikum rechts der Isar TU Münchenالرمز البريدي المؤكدميونخ، ألمانيا· التوظيف
أسئلة شائعة
What is 'Cholangiocarcinoma'?
It's a rare type of cancer that forms in the bile ducts, which are tubes that carry digestive fluid (bile) from your liver to your small intestine.
What does 'IDH1 mutation' mean?
This refers to a specific genetic change that can be found in some cancer cells. The study treatment, ivosidenib, is designed to target this particular change.
What is 'ivosidenib'?
It's a medication that is being studied to see if it can specifically target cancer cells that have the IDH1 mutation and prevent the cancer from coming back.
What is 'adjuvant chemotherapy'?
This is chemotherapy given after surgery to kill any remaining cancer cells and reduce the chance of the cancer coming back.
How long will I be followed up after treatment?
You will be followed up for a total of 48 months (4 years) from the start of the study, even after you finish taking the study drug.
كيفية معرفة المزيد
Thorsten Götze, Prof. Dr.
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نقاش
مناقشة المجتمع
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