Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 59
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced or metastatic pleural mesothelioma;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy.
- •Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
- •Adequate haematological, renal and liver function.
排除标准
- •Primary mesothelioma of peritoneum, pericardium and testes
- •Active, untreated central nervous system (CNS) metastasis.
- •Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment.
- •Known active autoimmune diseases.
- •Presence of other uncontrolled serious medical conditions.
研究组 & 干预措施
Cadonilimab combined with chemotherapy
All subjects in the group will be treated with Cadonilimab plus gemcitabine / vinorelbine / pemetrexed once every three weeks.
干预措施: Cadonilimab Combined with chemotherapy (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 2 year
defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
次要结局
- Disease Control Rate (DCR)(2 year)
- Progression Free Survival (PFS)(2 year)
- Duration of Response (DoR)(2 year)
- Overall Survival (OS)(2 year)
- Adverse Events (AEs)(2 year)
研究者
Jie Wang
Chief physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences