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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ivosidenib Monotherapy
Intervention: Ivosidenib (Drug)
Ivosidenib + Lenvatinib
Intervention: Ivosidenib (Drug)
Ivosidenib + Lenvatinib
Intervention: Lenvatinib (Drug)
Ivosidenib + PD-1/PD-L1 Inhibitor
Intervention: Ivosidenib (Drug)
Ivosidenib + PD-1/PD-L1 Inhibitor
Intervention: PD-1/PD-L1 inhibitor (Biological)
Ivosidenib + Lenvatinib + PD-1/PD-L1 Inhibitor
Intervention: Ivosidenib (Drug)
Ivosidenib + Lenvatinib + PD-1/PD-L1 Inhibitor
Intervention: Lenvatinib (Drug)
Ivosidenib + Lenvatinib + PD-1/PD-L1 Inhibitor
Intervention: PD-1/PD-L1 inhibitor (Biological)
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: From first dose of study drug until disease progression, death, or start of new anti-cancer therapy, assessed up to approximately 24 months.
Secondary Outcomes
- Disease Control Rate (DCR)(From first dose of study drug until disease progression, death, or start of new anti-cancer therapy, assessed up to approximately 24 months.)
- Progression-Free Survival (PFS)(From first dose of study drug until disease progression or death from any cause (whichever occurs first), assessed up to approximately 24 months.)
- Overall Survival (OS)(From enrollment (or first dose) until death from any cause, assessed up to approximately 36 months.)
- Duration of Response (DOR)(From the date of first documented response (CR or PR) until the date of disease progression or death, assessed up to approximately 24 months.)