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Not yet recruiting NCT07159217

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

Phase II Interventional Biliary Tract Cancer Disitamab Vedotin Lenvatinib Immune Checkpoint Inhibitors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Disitamab Vedotin, Lenvatinib, Pembrolizumab, Toripalimab.
Who it may be relevant to
Registry conditions: Biliary Tract Cancer, Disitamab Vedotin, Lenvatinib, Immune Checkpoint Inhibitors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Primary outcome measures

  • ORR, objective response rate [Time frame: 12 months after the last subject is enrolled]
Secondary outcome measures (5)
  • 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) [Time frame: 12 months after the last subject is enrolled]

Eligibility criteria

Inclusion criteria

  • Participants who voluntarily participate in this study, sign the written informed consent, and are able to comply with the protocol.
  • Age ≥ 18 years and any gender.
  • Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).
  • At least one measurable lesion (according to RECIST 1.1).
  • ECOG performance status score of 0-1.
  • Child-Pugh score ≤ 7 .
  • HER2 expression confirmed by: Immunohistochemistry (IHC 2+ or 3+); or Fluorescence in situ hybridization (FISH) with HER2/CEP17 ratio ≥2.0; or Next-generation sequencing (NGS) showing HER2 amplification.
  • No prior HER2-targeted therapy (including antibody-based agents, small-molecule TKIs, or antibody-drug conjugates) before randomization.
  • Expected survival > 12 weeks.
  • Adequate hematological and major organ function.

Exclusion criteria：

  • Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors.
  • Pregnant women (positive pregnancy test before medication) or lactating women.
  • Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients.
  • History of other active malignancies within 5 years prior to screening.
  • Presence of central nervous system metastasis and/or leptomeningeal metastasis.
  • Unhealed severe wounds, active ulcers, or untreated fractures.
  • Administration of live vaccines within 30 days prior to randomization.
  • Active autoimmune disease or history of autoimmune disease.
  • Presence of clinically significant gastrointestinal disorders.
  • Presence of clinically significant cardiovascular or cerebrovascular diseases.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Chinese Academy of Medical Sciences, Peking Union Medical College Hospital — Beijing

Publications

  • Shi F, Liu Y, Zhou X, Shen P, Xue R, Zhang M. Disitamab vedotin: a novel antibody-drug conjugates for cancer therapy. Drug Deliv. 2022 Dec;29(1):1335-1344. doi: 10.1080/10717544.2022.2069883. PMID 35506447

Identifiers

NCT: NCT07159217 · K8721

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗