跳至主要内容
临床试验/NCT04713059
NCT04713059Unknown不适用

The Affiliated Hospital of Qingdao University

The Affiliated Hospital of Qingdao University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
试验地点
1
主要终点
6m-PFS

研究概览

简要总结

Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function. The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded. This study was an open, exploratory single-arm, phase II trial. Enrolled patients received anlotinib (12mg, po. qd, d1-14) combined with toripalimab (240 mg, inv, over 30 min once every 2 weeks).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function.

排除标准

  • The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded.

结局指标

主要结局

6m-PFS

时间窗: 01.01.2019 to 01.01.2021

ORR

时间窗: 01.01.2019 to 01.01.2021

safety

时间窗: 01.01.2019 to 01.01.2021

次要结局

  • PFS(01.01.2019 to 01.01.2021)
  • OS(01.01.2019 to 01.01.2021)

研究者

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

zhangxiaochun

The Affiliated Hospital of Qingdao University

The Affiliated Hospital of Qingdao University

研究点 (1)

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