Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC): a Single Center, Single-arm Phase II Study (APICAL-CRC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objecitve response rate
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of the combination of Anlotinib and Sintilimab in advanced colorectal cancer as first-line treatment.
详细描述
Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. Sintilimab is a fully human IgG4 monoclonal antibody that binds to programmed cell death receptor-1 (PD-1), thereby blocking the interaction of PD-1 with its ligands (PD-L1 and PL-L2) and consequently helping to restore the endogenous antitumour T-cell response. In the present study, we design a single-arm, single center Phase II trial to evaluate the efficacy and safety of the combination of Anlotinib and Sintilimab in advanced colorectal cancer as first-line 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Anlotinib and Sintilimab
the combination of Anlotinib with Sintilimab as first-line treatment
干预措施: Anlotinib plus Sintilimab (Drug)
结局指标
主要结局
Objecitve response rate
时间窗: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
次要结局
- Deepness of response(Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks)
- Incidence of Treatment-related adverse Events(Through study completion, an average of 3 weeks)
- Progress Free Survival(Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks)
- Overall Survival(From date of treatment beginning until the date of death from any cause, through study completion, an average of 3 weeks)
- Disease control rate(Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks)
研究者
Yuan-Sheng Zang
Director
Shanghai Changzheng Hospital