NCT04866381Unknown2 期
An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study is being conducted to explore the efficacy of SHR-6390 and SHR-1020 in the treatment of esophageal squamous cell carcinoma after progression on PD-1 Antibody.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients who were diagnosed as esophageal squamous cell carcinoma by histopathology with at least one measurable lesion according to RECIST 1.1 criteria.
- •Must have had progressive disease after previous treatment with PD-1 inhibitor
- •ECOG score 0-2
- •The expected survival time is ≥ 12 weeks
- •Previous permanent discontinuation did not occur due to adverse events associated with immunotherapy, or the immunotreatment-related adverse events recovered to ≤1 grade
排除标准
- •Had other active malignant tumors within 5 years before entering the study
- •Had abnormal swallowing function or dysfunction of gastrointestinal absorption
- •The first study drug treatment was less than 28 days or 5 half-lives (in terms of longer) from the last radiotherapy, chemotherapy, targeted therapy or immunotherapy
- •Patients who have already received surgery within 28 days (biopsy for diagnosis is permitted)
- •Pregnant or lactating women
研究组 & 干预措施
SHR-6390
Experimental
SHR-6390
干预措施: SHR-6390 (Drug)
SHR-6390 combined with Camrelizumab (SHR-1210)
Experimental
SHR-6390 combined with Camrelizumab (SHR-1210)
干预措施: SHR-6390 + Camrelizumab (SHR-1210) (Drug)
Camrelizumab (SHR-1210) combined with SHR-1020
Experimental
Camrelizumab (SHR-1210) combined with SHR-1020
干预措施: Camrelizumab (SHR-1210) + SHR-1020 (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 1 year
Objective Response Rate is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1 criteria.
次要结局
- Subject safety(Up to 1 year)
- Progression-Free-Survival(Up to 1 year)
- Overall survival(Up to 1 year)
研究者
研究点 (1)
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