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NOT YET RECRUITING
NCT07159217
PHASE2

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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

DRUG

Disitamab Vedotin

2.0 mg/kg administered intravenously every three weeks

DRUG

Lenvatinib

≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily

DRUG

Pembrolizumab

200 mg intravenously every three weeks

DRUG

Toripalimab

240 mg intravenously every three weeks

DRUG

Camrelizumab

200 mg intravenously every three weeks

Locations (1)

Chinese Academy of Medical Sciences, Peking Union Medical College Hospital

Beijing, China