drugset / Trial / NCT07159217
Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer
NaSingle-groupOpen-labelTreatment
Summary
This trial is a single-arm exploratory phase II clinical study initiated by the investigator. Subjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.
Timeline
- Start
- 2025-08-30
- Primary completion
- 2027-05-31
- Completion
- 2028-05-31
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Disitamab Vedotin | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Lenvatinib | Small molecule | 8 mg | Oral |
| Subject | Lenvatinib | Small molecule | 12 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |