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.

Recruiting Phase 2 Interventional Study
Biliary Tract Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Peking Union Medical College Hospital · Other
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About This Trial
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 cance…
Trial Locations
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Eligibility Criteria
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…
Contacts

Chengjie Li

13733879582

1624271942@qq.com

CONTACT