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Набор скоро начнётся NCT07159217

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

Фаза II С лечением Biliary Tract Cancer Disitamab Vedotin Lenvatinib Immune Checkpoint Inhibitors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Disitamab Vedotin, Lenvatinib, Pembrolizumab, Toripalimab.
Кому может быть актуально
Состояния в реестре: Biliary Tract Cancer, Disitamab Vedotin, Lenvatinib, Immune Checkpoint Inhibitors. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

  • ORR, objective response rate [Срок оценки: 12 months after the last subject is enrolled]
Вторичные конечные точки (5)
  • PFS, progression free survival [Срок оценки: 12 months after the last subject is enrolled]
  • OS, overall survival [Срок оценки: 12 months after the last subject is enrolled]
  • DCR, disease control rate [Срок оценки: 12 months after the last subject is enrolled]
  • DoR, duration of response [Срок оценки: 12 months after the last subject is enrolled]
  • Adverse events (AE) and serious adverse events (SAE) [Срок оценки: 12 months after the last subject is enrolled]

Критерии участия

Критерии включения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Chinese Academy of Medical Sciences, Peking Union Medical College Hospital — Пекин

Публикации

  • 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

Идентификаторы

NCT: NCT07159217 · K8721

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗