NCT07159217

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Cancer
• Disitamab Vedotin
• Lenvatinib
• Immune Checkpoint Inhibitors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-30
• Primary completion: 2027-05-31
• Completion: 2028-05-31
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: China