A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Официальное название

An Open, Multicenter Phase II Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Обзор

This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.

Вмешательства

• Препарат SHR-A1811
  SHR-A1811.
• Препарат SHR-1316
  SHR-1316.
• Препарат SHR-8068
  SHR-8068.

Первичные конечные точки

• Objective response rate (ORR) of the SHR-A1811 combination evaluated by investigators [Срок оценки: Screening up to study completion, an average of 3 year.]

Вторичные конечные точки (5)

• Duration of response (DoR) of the SHR-A1811 combination evaluated by investigators [Срок оценки: Screening up to study completion, an average of 3 year.]
• Disease control rate (DCR) of the SHR-A1811 combination evaluated by investigators [Срок оценки: Screening up to study completion, an average of 3 year.]
• Progression free survival (PFS) of the SHR-A1811 combination evaluated by investigators [Срок оценки: Screening up to study completion, an average of 3 year.]
• Overall survival (OS) of the SHR-A1811 combination evaluated by investigators [Срок оценки: Screening up to study completion, an average of 3 year.]
• Adverse events (AEs) [Срок оценки: Screening up to study completion, an average of 3 year.]

Критерии участия

Критерии включения

• Age 18-75 years old (including both ends), male or female;
• ECOG-PS score: 0 or 1;
• Expected survival ≥ 12 weeks;
• Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
• Subjects who had not previously received any systemic antitumor therapy were allowed to have previously received radical therapy, and had received the last dose of radical therapy for at least 6 months until disease recurrence;
• According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
• The main organ function is normal, in line with the program requirements;
• Consent to contraception.

Критерии исключения

• Other active malignancies within 5 years or at the same time;
• Local antitumor therapy was received within 4 weeks prior to initiation of treatment;
• Subjects with biliary obstruction should be excluded;
• There is active autoimmune disease or a history of autoimmune disease that may recur;
• Known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
• Severe infection within 4 weeks prior to initiation of study treatment;
• Active hepatitis B virus (HBV) infection;
• Have serious cardiovascular and 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 · 2 центра

• Affiliated Cancer Hospital of Harbin Medical University — Харбин
• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT06778031 · SHR-A1811-215

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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