Actively Recruiting
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.
Led by Peking Union Medical College Hospital · Updated on 2025-12-15
300
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate voluntarily
- Confirmed presence of IDH1 mutation by genetic testing
- Newly diagnosed advanced or metastatic disease, or recurrence more than 6 months after surgery
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of 3 months or more
- Adequate blood, liver, and kidney function
- Use of highly effective contraception for women of childbearing potential and men
You will not qualify if you...
- Previous treatment with ivosidenib
- Diagnosis of ampulla of Vater cancer
- Pregnant or breastfeeding women
- Known allergy to any study drug components
- Local anti-tumor therapy or major surgery within 4 weeks before starting the study
- Uncontrolled high blood pressure
- Significant heart disease
- Active or untreated central nervous system metastases
- Active autoimmune disease
- Uncontrolled active infections such as hepatitis B, hepatitis C, or HIV
- Significant bleeding risk or history
- Severe wounds that are not healing
- History of organ transplantation
- Participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Peking Union Medical College Hospital Outpatient Department
Beijing, China
Actively Recruiting
Research Team
C
Chengjie Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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