NCT04803851招募中1 期
Anlotinib Plus Anti-PD-1 Antibody AK105 as Third or More-line Therapy for Advanced Pancreatic Cancer: a Prospective, Single-arm, Open-label, Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Disease control rate (DCR) based on RECIST v. 1 1
研究概览
简要总结
This study was designed to explore the clinical efficacy of Anlotinib combined with Anti-PD-1 antibody AK105 in the treatment of third- and above -line advanced pancreatic cancer patients, in order to find a better therapy strategy for pancreatic cancer patients.
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
- •locally advanced or metastatic pancreatic cancer (PC),
- •histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma,
- •failed to second-line chemotherapy for PC,
- •18-75 years of age,
- •an Eastern Cooperative Oncology Group performance status score of 0 to 1,
- •adequate organ functions
排除标准
- •had received PD 1 /CTLA 4 antibody treatment
- •had received anti-VEGFR inhibitors or antibodies
研究组 & 干预措施
Treatment group
Experimental
Anlotinib plus AK105
干预措施: Anlotinib plus AK105 (Drug)
结局指标
主要结局
Disease control rate (DCR) based on RECIST v. 1 1
时间窗: 6 weeks
Disease control rate (DCR) based on RECIST v. 1 1 by investigators
次要结局
- Objective response rate (ORR) based on RECIST V. 1.1(6 weeks)
- Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression(6 weeks)
- Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause(6 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(6 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Apatinib Plus Sintilimab in Advanced Gastric Cancer Refractory to at Least Two Previous Chemotherapy RegimensAdvanced Metastatic Gastric CancerNCT04089657Fujian Cancer Hospital40
Unknown
2 期
PD-1 Antibody + Apatinib Mesylate in 2+ Line Serum AFP-elevated Gastric AdenocarcinomaAFPGastric CancerNCT04006821China Medical University, China30
Unknown
早期 1 期
A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal CancerEsophageal Squamous Cell CarcinomaNCT03940001Zhejiang Cancer Hospital20
Unknown
2 期
SHR-1210 in Combination With Anlotinib in Patients With Advanced or Metastatic Esophageal Squamous Cell CancerSHR-1210AnlotinibAdvanced Esophageal Squamous Cell CancerNCT04797507Peking Union Medical College Hospital33
Unknown
2 期
Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid CancerThyroid CancerNCT04612894Fudan University31