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临床试验/NCT06416930
NCT06416930尚未招募2 期

Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma

Cancer Institute and Hospital, Chinese Academy of Medical Sciences0 个研究点目标入组 59 人开始时间: 2024年6月20日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jie Wang

Chief physician

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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