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New treatment option for Biliary Tract Cancer
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.
ClinicalTrials.gov ID: NCT07282262
What this study is testing
What is Ivosidenib?
Ivosidenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for biliary tract cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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).
You likely can't join if
- 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:
See the full eligibility 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.
- 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 treatment clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.