跳至主要内容
临床试验/NCT04806243
NCT04806243Unknown2 期

A Phase II, Second-line, Single-arm Clinical Trial of Carelizumab Combined With Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年5月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
69
试验地点
1
主要终点
os(overall survival)

研究概览

简要总结

To investigate the efficacy and safety of carelizumab combined with regorafenib in second-line treatment for patients with primary hepatocellular carcinoma.

详细描述

Currently, there is little experience in the application of targeted drugs combined with immunotherapy. Through this study, we hope to explore the optimal population for the use of carelizumab combined with regorafenib in the second-line treatment of hepatocellular carcinoma (HCC), as well as the efficacy and safety.

This research is a single-center trials phase II second-line, single arm, explore the clinical outcome of treatment.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Not convenient to disclose

排除标准

  • Not convenient to disclose

研究组 & 干预措施

Carelizumab Combined With Regorafenib arm

Experimental

干预措施: Regorafenib Pill&Camrelizumab (Drug)

结局指标

主要结局

os(overall survival)

时间窗: 21 days

overall survival

次要结局

  • ORR(Overall Response Rate)(21 days)
  • DCR(disease control rate)(21 days)
  • DoR(21 days)
  • PFS(progression-free survival)(21 days)
  • TTP(Time-To-Progression)(21 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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