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

Not Applicable

Not yet recruiting

• Conditions: Biliary Tract Cancer; Disitamab Vedotin; Lenvatinib; Immune Checkpoint Inhibitors
• Interventions: Drug: Disitamab Vedotin; Drug: Lenvatinib; Drug: Pembrolizumab; Drug: Toripalimab; Drug: Camrelizumab

• Registration Number: NCT07159217
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-18
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study Start: 2025-08-30
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2027-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor	Disitamab Vedotin	Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor	Lenvatinib	Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor	Pembrolizumab	Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor	Toripalimab	Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor	Camrelizumab	Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)

Primary Outcome Measures

Name	Time	Method
ORR, objective response rate	12 months after the last subject is enrolled

Secondary Outcome Measures

Name	Time	Method
DCR, disease control rate	12 months after the last subject is enrolled
PFS, progression free survival	12 months after the last subject is enrolled
DoR, duration of response	12 months after the last subject is enrolled
OS, overall survival	12 months after the last subject is enrolled
Adverse events (AE) and serious adverse events (SAE)	12 months after the last subject is enrolled	To evaluate safety, incidence and outcome of adverse events (AE), and serious adverse events (SAE)

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences, Peking Union Medical College Hospital; 🇨🇳 Beijing, China