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Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer
Sponsor: Peking Union Medical College Hospital
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.
Official title: A Prospective Exploratory Phase II Study of Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for the Treatment of HER2-positive Advanced Biliary Tract Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2025-08-30
Completion Date
2028-05-31
Last Updated
2025-09-08
Healthy Volunteers
No
Interventions
Disitamab Vedotin
2.0 mg/kg administered intravenously every three weeks
Lenvatinib
≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily
Pembrolizumab
200 mg intravenously every three weeks
Toripalimab
240 mg intravenously every three weeks
Camrelizumab
200 mg intravenously every three weeks
Locations (1)
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, China