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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07159217
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Disitamab Vedotin — DRUG
    2.0 mg/kg administered intravenously every three weeks
  • Lenvatinib — DRUG
    ≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily
  • Pembrolizumab — DRUG
    200 mg intravenously every three weeks
  • Toripalimab — DRUG
    240 mg intravenously every three weeks
  • Camrelizumab — DRUG
    200 mg intravenously every three weeks

Study Details

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.

Key Dates

Start date
Aug 30, 2025
Status verified
Aug 2025
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Disitamab vedotin combined with lenvatinib and PD-1 inhibitor
    Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)

Primary Outcome Measure

ORR, objective response rate [ Time Frame: 12 months after the last subject is enrolled ]

Central Contacts

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