NCT06879145招募中2 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Phase II: pCR evaluated by researchers;
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
- •Enough organ function
排除标准
- •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
研究组 & 干预措施
Treatment with SHR-A2102 in combination with a fixed dose of Adebrelimab
Experimental
干预措施: SHR-A2102；Adebrelimab (Drug)
结局指标
主要结局
Phase II: pCR evaluated by researchers;
时间窗: Three months after the last subject underwent RC+PLD surgery
Phase III: EFS assessed by BICR；
时间窗: 5 years after the first medication of the last subject
次要结局
- pCR(Three months after MIBC surgery)
- ORR(from first dose to disease progression or death, whichever comes first, up to 3 years)
- DCR(from first dose to disease progression or death, whichever comes first, up to 3 years)
- EFS(from first dose to disease progression or death, whichever comes first, up to 3 years)
- DFS(from first dose to disease progression or death, whichever comes first, up to 3 years)
- OS(from first dose to disease progression or death, whichever comes first, up to 3 years)
- R0 resection rate(One month after the last subject underwent RC+PLD surgery)
- AE(from Day1 to 90 days after last dose)
研究者
研究点 (1)
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