NCT03187314已完成2 期
Phase II Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Unresectable Esophageal Cancer
Hangzhou Cancer Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年6月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer
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
- •age:18-75 years, male or femal.
- •Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease.
- •Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.
- •Can provide either a newly obtained or archival tumor tissue sample.
- •Life expectancy of greater than 12 weeks.
- •Adequate organ function.
- •Female: child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 3 months after the last dose of SHR-
- •Patient has given written informed consent.
排除标准
- •Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- •Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- •Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
- •Known central nervous system (CNS) metastases.
- •Subjects with any active autoimmune disease or history of autoimmune disease.
- •Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- •Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
- •History of Interstitial Pneumonia or active non-infectious pneumonitis.
- •Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
- •Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
- •Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation.
- •Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treament. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalen for replacement therapy.
- •Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.
- •Received a live vaccine within 4 weeks of the first dose of study medication.
- •Pregnancy or breast feeding.
- •Decision of unsuitableness by principal investigator or physician-in-charge.
研究组 & 干预措施
Experimental Group
Experimental
Radiation to 60 Gy, 5 x per week, for 6 weeks. Radiation begun the day after the first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.
干预措施: Radiation (Drug)
Experimental Group
Experimental
Radiation to 60 Gy, 5 x per week, for 6 weeks. Radiation begun the day after the first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.
干预措施: SHR-1210 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 4-8 weeks
ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1.
次要结局
- Health-related quality of life (HRQoL)(From baseline to one year after RT.)
- Overall survival(year 0 - year 3)
- Local-regional free survival (LRFS)(year 0 - year 3)
- Treatment-emergent adverse events(year 0 - year 1)
研究者
Shixiu Wu
Professor
Hangzhou Cancer Hospital
研究点 (1)
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