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An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.

RecruitingPhase 2Ages 18 Years - 80 YearsAllPeking Union Medical College Hospital
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In plain words

What the trial is, and whether it could suit you

This is a multicenter, non-randomized, umbrella, open-label phase II clinical study, aiming to observe and evaluate, as well as explore the efficacy and safety of precision targeted therapy based on NGS technology for IDH1-mutated patients, specifically the combination of ivosidenib with multi-target tyrosine kinase inhibitors represented by lenvatinib or PD-1/PD-L1 in advanced biliary tract cancer patients who have failed systemic chemotherapy.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria * Voluntary Participation: Signed informed consent. * Genetic Mutation: Presence of an IDH1 mutation confirmed by genetic testing. * Disease Status: * Newly diagnosed, untreated advanced/metastatic disease; OR * Recurrence \>6 months after curative-intent surgery (with or without adjuvant therapy). * Measurable Disease: At least one measurable lesion per RECIST 1.1. * Performance Status: ECOG performance status of 0 or 1. * Life Expectancy: ≥3 months. * Organ Function: Adequate hematological, hepatic, and renal function. * Contraception: Use of highly effective contraception for women of childbearing potential and men. Exclusion Criteria * Prior Treatment: Previous treatment with Ivosidenib. * Cancer Type: Ampulla of Vater cancer. * Pregnancy: Pregnant or breastfeeding women. * Allergy: Known hypersensitivity to any component of the study drugs. * Recent Therapy: Local anti-tumor therapy or major surgery within 4 weeks prior to initiation. * Medical Conditions: * Uncontrolled hypertension. * Significant cardiovascular disease. * Active or untreated CNS metastases. * Active autoimmune disease. * Uncontrolled active infection (e.g., HBV, HCV, HIV). * Significant bleeding tendency or history. * Severe non-healing wounds. * History of organ transplantation. * Concurrent Participation: Participation in another interventional clinical trial.
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What it tests

  • Ivosidenib
  • Lenvatinib
  • PD-1/PD-L1 inhibitor
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Where

1 site
Beijing Peking Union Medical College Hospital Outpatient Department
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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