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.
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