A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer

Официальное название

An Open, Multicenter Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer

Обзор

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-8068 injection in combination with anti-tumor therapies in subjects with colorectal cancer.

Вмешательства

• Препарат SHR-8068 Injection
  SHR-8068 injection.
• Препарат Adebrelimab Injection
  Adebrelimab injection.
• Препарат Bevacizumab Injection
  Bevacizumab injection.

Первичные конечные точки

• Pathological Complete Response (pCR) [Срок оценки: About 7 months.]
• Progression Free Survival (PFS) [Срок оценки: About 18 months.]

Вторичные конечные точки (8)

• Clinical Complete Response (cCR) [Срок оценки: About 60 months.]
• Disease Free Survival (DFS) [Срок оценки: About 60 months.]
• Event Free Survival (EFS） [Срок оценки: About 60 months.]
• Overall Survival (OS) [Срок оценки: About 60 months.]
• Duration of Response (DoR) [Срок оценки: About 18 months.]
• Overall Response Rate (ORR) [Срок оценки: About 18 months.]
• Disease Control Rate (DCR) [Срок оценки: About 18 months.]
• Adverse Events (AEs) [Срок оценки: Up to about 18 months.]

Критерии участия

Критерии включения

• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
• Male or female ≥ 18 years old and ≤75 years old.
• ECOG performance status of 0-1.
• Part A with a life expectancy of ≥2 years. Part B with a life expectancy of ≥12 weeks.
• Need to provided tumor tissue samples for genetic testing.

Критерии исключения

• Part B: Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis.
• Part B: Systemic antitumor therapy was received 4 weeks before the start of the study.
• Part B: Palliative radiotherapy was completed within 14 days before the first dose.
• Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria.
• Subjects with known or suspected interstitial pneumonia.
• Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
• Have poorly controlled or severe cardiovascular disease.
• Subjects with active hepatitis B or active hepatitis C.
• A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
• The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
• Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.

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 Sixth Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT07071714 · SHR-8068-206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗