drugset / Trial / NCT07159217

Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer

NCT07159217

Phase 2 Not yet recruiting 65 enrolled Peking Union Medical College Hospital
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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications