A Single Arm, Phase II Clinical Study of Chemoradiationtherapy Combined With QL1706 (Anti-CTLA-4 and PD-1 Antibody) in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- PFS assessed by investigators
研究概览
简要总结
This is a single arm, multi-center Phase II Study. This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of Chemoradiationtherapy combined with QL1706 (anti-CTLA-4 and PD-1 antibody) in patients with unresectable locally advanced esophageal squamous cell carcinoma.
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
- •Subjects participate voluntarily and sign informed consent.
- •age:18-75 years, male or female.
- •Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M
- •At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
排除标准
- •Patients who have a history of esophageal cancer surgery.
- •Previous history of fistula caused by primary tumor infiltration.
- •a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation.
- •Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention.
- •Major surgery or serious trauma within 4 weeks before the first use of the study drug.
研究组 & 干预措施
QL1706 plus Chemotherapy and Radiotherapy
Radiotherapy: Total 50.4Gy/28 fraction ,1.8Gy per time，5 fractions per week.
QL1706 will be administered at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment). QL1706 will be administered up to 1 year.
Chemotherapy: Taxol 135 mg/m2, days 1, 22; Cisplatin 25 mg/m2, day 1-3, day 22-24.
干预措施: QL1706 (Drug)
结局指标
主要结局
PFS assessed by investigators
时间窗: Up to approximately 2 years.
Progression-free survival assessed by investigators
次要结局
- OS(1year and 3years)
- DoR(Up to approximately 2 years)
- ORR(Up to approximately 2 years)
- The rates and severity of Adverse Events, Serious Adverse Events(Through study completion, up to approximately 2 years)