Personalized Medicine for Advanced Biliary Cancer Patients
Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial
UNICANCER
800 participants
Jul 18, 2024
INTERVENTIONAL
Conditions
Summary
The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment. The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Dose 20 mg once a day (QD)
Dose 500 mg QD
Dose: Patients \< 70 kg: 1800 mg every 3 weeks (Q3W), Patients ≥ 70 kg: 2400 mg Q3W
Loading dose 8 mg/kg, then 6 mg/kg Q3W (Combination with neratinib)
Dose: 240 mg QD (combination with trastuzumab)
Dose: 450 mg QD (Combination with binimetinib)
Dose: 45 mg twice a day (BID) (Combination with encorafenib)
Dose: 200 mg QD or 300 mg QD
Dose: 25 mg/m2 IV on days 1 and 8 Q3W (CISGEM)
Dose: 1000 mg/m2 IV on days 1 and 8 Q3W (CISGEM)
Locations(69)
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NCT05615818