A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)

Официальное название

A Phase III, Randomized, Controlled, Open-Label, Multicenter Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer (BTC)

Обзор

This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.

Вмешательства

• Препарат SHR-8068 Injection
  SHR-8068 injection.
• Препарат Adebrelimab Injection
  Adebrelimab injection.
• Препарат Gemcitabine Hydrochloride for Injection
  Gemcitabine Hydrochloride for injection.
• Препарат Cisplatin Injection
  Cisplatin injection.
• Препарат Durvalumab Injection
  Durvalumab injection.

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: Up to 15 months.]

Вторичные конечные точки (8)

• Disease Control Rate (DCR) [Срок оценки: Up to 7 months.]
• Duration of Response (DoR) [Срок оценки: Up to 7 months.]
• Progression free Survival (PFS) [Срок оценки: Up to 7 months.]
• Objective Response Rate (ORR) [Срок оценки: Up to 7 months.]
• Time to Progression (TTP) [Срок оценки: Up to 7 months.]
• Time to Response (TTR) [Срок оценки: Up to 7 months.]
• Adverse events (AEs) [Срок оценки: Up to approximately 15 months.]
• Serious adverse events (SAEs) [Срок оценки: Up to approximately 15 months.]

Критерии участия

Критерии включения

• Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;
• No previous systemic anti-tumor treatment has been received;
• At least one measurable lesion that complies with the RECIST v1.1 standard;
• ECOG PS score: 0-1 point;
• The expected survival period is ≥ 3 months;
• Good organ function level;
• Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;
• Patients voluntarily joined this study and signed informed consent.

Критерии исключения

• Other pathological types of cholangiocarcinoma other than adenocarcinoma;
• Malignant tumor of the ampulla;
• Have had or concurrently suffered from other malignant tumors;
• Those with concurrent biliary obstruction and at risk of biliary tract infection;
• Those with any active or known autoimmune diseases.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital, College of Medicine, Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07229625 · SHR-8068-303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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