Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)

Официальное название

A Randomized, Open, Multicenter Phase II/III Clinical Study of SHR-A2102 for Injection Combined With Adebrelimab (SHR-1316) in Perioperative Treatment of Muscular Invasive Bladder Cancer (MIBC)

Обзор

In phase II, the main objective is to evaluate the efficacy of SHR-A2102 combined with Adebrelimab in the treatment of muscular invasive bladder cancer (MIBC); The main objective of phase III is to evaluate the efficacy of SHR-A2102 for injection combined with Adebrelimab compared with gemcitabine combined with cisplatin in the treatment of muscular invasive bladder cancer (MIBC).

Вмешательства

• Препарат SHR-A2102；Adebrelimab
  Treatment with SHR-A2102 in combination with fixed dose Adebrelimab

Первичные конечные точки

• Phase II: pCR evaluated by researchers; [Срок оценки: Three months after the last subject underwent RC+PLD surgery]
• Phase III: EFS assessed by BICR； [Срок оценки: 5 years after the first medication of the last subject]

Вторичные конечные точки (8)

• ORR [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• DCR [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• pCR [Срок оценки: Three months after MIBC surgery]
• EFS [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• DFS [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• OS [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• R0 resection rate [Срок оценки: One month after the last subject underwent RC+PLD surgery]
• AE [Срок оценки: from Day1 to 90 days after last dose]

Критерии участия

Критерии включения

\- 1.18-80 years old, gender not limited. 2.The patient voluntarily joined this study and signed informed consent 3.ECOG score is 0 or 1 4.Expected survival period ≥ 2 years. 5.Pathology and imaging diagnosis of non metastatic muscle invasive bladder cancer 6.There are assessable lesions that meet the RECIST 1.1 criteria 7. Enough organ function

Критерии исключения

• Received systemic anti-tumor therapy 4 weeks before starting the study treatment
• The toxicity and/or complications of previous anti-tumor treatments have not recovered to NCI-CTCAE ≤ 1 level
• Subjects known or suspected to have interstitial pneumonia
• Individuals with any active, known or suspected autoimmune diseases
• There are clinical symptoms or diseases of the heart that have not been well controlled
• Diagnosed with any other malignant tumor
• Subjects who have experienced severe infections within 28 days prior to their first medication use
• History of immunodeficiency
• Use of attenuated live vaccine within 28 days prior to the first study medication
• Have undergone major surgery within 28 days prior to the first administration of medication

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

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06879145 · SHR-A2102-303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗