Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
This research is looking at a new combination of medicines for a type of cancer that starts in the bile ducts, called cholangiocarcinoma. This is for people whose cancer has a specific genetic change called an IDH1 mutation and is locally advanced, unresectable, or has spread to other parts of the body. The study combines ivosidenib, durvalumab, and standard chemotherapy (gemcitabine/cisplatin). We want to find out if this combination is safe, what the right dose is, and how well it works as a first treatment option. The study runs in two main parts, first checking safety and dosage, then expanding to see its effectiveness. Regular hospital visits, tests, and follow-up will be part of taking part.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is investigating a new way to treat a specific type of cancer called cholangiocarcinoma, which affects the bile ducts. This cancer is quite rare and can be challenging to treat, especially when it's advanced. The focus of this research is on patients whose cancer cells have a particular genetic error, known as an IDH1 mutation. This mutation can affect how cancer cells grow, and certain medicines are designed to target it.
The study combines several different treatments: ivosidenib, which specifically targets the IDH1 mutation; durvalumab, a type of immunotherapy that helps your body's immune system fight cancer; and standard chemotherapy drugs (gemcitabine and cisplatin). The aim is to see if using these treatments together can be more effective than current approaches, by attacking the cancer from different angles. This is being explored as an initial (first-line) treatment option for patients before they've had other therapies for advanced disease.
This research is important because it could lead to better treatment options for people with this specific type of bile duct cancer. By understanding if this combination is safe and effective, doctors can potentially offer new hope and improved outcomes for patients with IDH1-mutated cholangiocarcinoma.
النقاط الرئيسية
- Tests a new combination of treatments for bile duct cancer with a specific genetic change (IDH1 mutation).
- Aims to find out if this combination is safe and effective as a first treatment.
- يتضمن زيارات منتظمة للمستشفى للعلاج والمراقبة.
- Includes a mix of oral medication, immunotherapy, and chemotherapy.
- Follow-up will continue for several months after treatment ends.
- المشاركة طوعية، ويمكنك الانسحاب في أي وقت.
من قد يكون مؤهلاً؟
To join this study, you must have a confirmed diagnosis of bile duct cancer (cholangiocarcinoma) that is locally advanced, cannot be removed by surgery, or has spread. Importantly, your cancer cells must show a specific genetic change called an IDH1 mutation.
You also need to be at least 18 years old and generally well enough to take part, with normal bone marrow, liver, and kidney function. This means your body needs to be able to handle the treatments involved. Doctors will check these things with blood tests.
There are also reasons you might not be able to join. For example, if you've already had many treatments for your advanced bile duct cancer, or if you've previously received certain types of immunotherapy. You also shouldn't have any other serious medical conditions that might make taking part risky.
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.
- Do you have a confirmed diagnosis of advanced bile duct cancer?
- Has your doctor confirmed your cancer has the IDH1 genetic mutation?
- هل عمرك 18 سنة أو أكثر؟
- Are you generally well, with good blood counts, liver, and kidney function?
- Have you had limited or no prior treatment for your advanced cancer?
ماذا يتضمن المشاركة؟
If you join this study, you will receive a combination of medicines: ivosidenib, durvalumab, gemcitabine, and cisplatin. The first 8 treatment cycles will combine all these medicines, with durvalumab continuing after that. Each treatment cycle for the first 8 cycles lasts 21 days, and then subsequent cycles will be 28 days long.
During your treatment, you'll have regular hospital visits. In the first cycle, you'll visit on days 1, 8, and 15. For cycles 2 to 8, you'll visit on days 1 and 8. After that, you'll visit on day 1 of each new cycle. These visits will involve various checks, including blood tests, heart readings (ECG), measuring your vital signs (like blood pressure and temperature), and a physical examination to monitor your health and how the treatment is working.
After your treatment period finishes, you'll have follow-up safety visits approximately 30 and 90 days later. Following these, doctors will continue to check in with you about your survival every three months for an extended period. The study involves two phases: a first phase to find the best and safest dose of the medicine combination, followed by an expansion phase to see how well that dose works.
المخاطر والفوائد المحتملة
المواقع (38)
- Cancer and Blood Speciality Clinic - Los Alamitosالرمز البريدي المؤكدلوس ألاميتوس، الولايات المتحدة· التوظيف
- Usc Norris Comprehensive Cancer Centerالرمز البريدي المؤكدلوس أنجلوس، الولايات المتحدة· التوظيف
- Northwestern Medicineالرمز البريدي المؤكدشيكاغو، الولايات المتحدة· التوظيف
- مركز ميموريال سلون كيترينج للسرطانالرمز البريدي المؤكدنيويورك، الولايات المتحدة· التوظيف
- Duke Universityالرمز البريدي المؤكددرهام، الولايات المتحدة· التوظيف
- Gibbs Cancer Centerالرمز البريدي المؤكدSpartanburg, United States· التوظيف
- Tennesse Oncology - Elliston Place Plazaالرمز البريدي المؤكدناشفيل، الولايات المتحدة· التوظيف
- The University of Texas Md Anderson Cancer Centerالرمز البريدي المؤكدهيوستن، الولايات المتحدة· التوظيف
- الصحة ألفريدالرمز البريدي المؤكدملبورن، أستراليا· التوظيف
- Hospital de Amor - Barretosالرمز البريدي المؤكدبارريتوس، البرازيل· التوظيف
- Oncoclinicas Mgالرمز البريدي المؤكدBelo Horizonte, Brazil· التوظيف
- CIONCالرمز البريدي المؤكدكوريتيبا، البرازيل· التوظيف
أسئلة شائعة
What is an IDH1 mutation?
It's a specific genetic change in your cancer cells that can make them grow. This study's treatment is designed to target this change.
What does 'first-line therapy' mean?
This means the study drugs would be the first treatment you receive for your advanced bile duct cancer, before other main treatments.
ما نوع الاختبارات التي سأخضع لها؟
You'll have regular blood tests, heart checks (ECGs), vital sign measurements, and physical examinations during your hospital visits.
كم من الوقت سأكون في الدراسة؟
The treatment period varies, but you'll have follow-up visits for safety for about 3 months after treatment, and then survival checks every three months.
هل يمكنني مغادرة الدراسة في أي وقت؟
Yes, you can choose to stop participating in the study at any point, and this won't affect your ongoing medical care.
كيفية معرفة المزيد
Institut de Recherches Internationales Servier (I.R.I.S.) Clinical Studies Department
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نقاش
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