A Phase 2 interventional study of Ivosidenib and Lenvatinib in Biliary Tract Cancer, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
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.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's planned enrollment of 300 is above the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Drug: Ivosidenib
Drug: Ivosidenib · Drug: Lenvatinib
Drug: Ivosidenib · Biological: PD-1/PD-L1 inhibitor
Drug: Ivosidenib · Drug: Lenvatinib · Biological: PD-1/PD-L1 inhibitor
Oral, selective, small-molecule inhibitor of the mutant isocitrate dehydrogenase 1 (IDH1) enzyme. Administered at a dose of 500 mg, taken orally once daily. This is the core investigational drug in all study arms.
Oral, multi-targeted tyrosine kinase inhibitor. Administered at a weight-based dose (8 mg for body weight \<60 kg or 12 mg for body weight ≥60 kg), taken orally once daily. Used in combination arms.
Intravenous immune checkpoint inhibitor. Specific agent (e.g., Pembrolizumab, Durvalumab, Toripalimab, or Tislelizumab) may be chosen based on local availability and patient access. Administered at standard doses (e.g., 200 mg, 1500 mg, or 240 mg) via IV infusion every three weeks. Used in combination arms.
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.
Disease Control Rate (DCR)
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.
Progression-Free Survival (PFS)
Time frame: 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)
Time frame: From enrollment (or first dose) until death from any cause, assessed up to approximately 36 months.
Duration of Response (DOR)
Time frame: From the date of first documented response (CR or PR) until the date of disease progression or death, assessed up to approximately 24 months.
Plan to share: No
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Peking Union Medical College Hospital