A Phase 2 interventional study of Disitamab Vedotin and Lenvatinib in Biliary Tract Cancer, Disitamab Vedotin and Lenvatinib, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
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.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's planned enrollment of 65 is above the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria：
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)
Drug: Disitamab Vedotin · Drug: Lenvatinib · Drug: Pembrolizumab · Drug: Toripalimab · Drug: Camrelizumab
2.0 mg/kg administered intravenously every three weeks
≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily
200 mg intravenously every three weeks
240 mg intravenously every three weeks
200 mg intravenously every three weeks
ORR, objective response rate
Time frame: 12 months after the last subject is enrolled
PFS, progression free survival
Time frame: 12 months after the last subject is enrolled
OS, overall survival
Time frame: 12 months after the last subject is enrolled
DCR, disease control rate
Time frame: 12 months after the last subject is enrolled
DoR, duration of response
Time frame: 12 months after the last subject is enrolled
Adverse events (AE) and serious adverse events (SAE)
To evaluate safety, incidence and outcome of adverse events (AE), and serious adverse events (SAE)
Time frame: 12 months after the last subject is enrolled
Plan to share: No
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital