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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivosidenib Monotherapy | Experimental |
| |
| Ivosidenib + Lenvatinib | Experimental |
| |
| Ivosidenib + PD-1/PD-L1 Inhibitor | Experimental |
| |
| Ivosidenib + Lenvatinib + PD-1/PD-L1 Inhibitor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivosidenib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | From first dose of study drug until disease progression, death, or start of new anti-cancer therapy, assessed up to approximately 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengjie Li | Contact | 13733879582 | 1624271942@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Peking Union Medical College Hospital Outpatient Department | Recruiting | Beijing | China |
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| Lenvatinib | Drug | 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. |
|
| PD-1/PD-L1 inhibitor | Biological | 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. |
|
| 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. |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000627630 | ivosidenib |
| C531958 | lenvatinib |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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