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

NCT07159217 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-09-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2027-05-31
Completion
2028-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159217 on ClinicalTrials.gov