Phase II Study of Neoadjuvant Anti-PD-1 Antibody SHR-1210 and Radiation in Resectable Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response Rate
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 followed by surgery in treating patients with resectable 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
- •Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment.
- •With resectable disease of primary tumor in middle or lower thoracic esophagus and clinical stage Ⅱa-Ⅲ.
- •age:18-75 years, male or female.
- •Can provide either a newly obtained or archival tumor tissue sample.
- •Life expectancy of greater than 12 weeks.
- •Without serious system dysfunction and could tolerate radiotherapy.
- •Patients must have normal marrow function with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×109/L，a neutrophil count of ≥2.0×109/L, , a platelet count of ≥100×109/L, a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.5 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL.
- •Patients must have normal electrocardiogram results and no history of congestive heart failure.
- •Women of childbearing age should voluntarily take contraceptive measures.
- •Without drug addition
- •Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events
- •Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
排除标准
- •Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- •With unresectable disease including any T4b or M1 disease
- •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 treatment. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone orequivalent for replacement therapy.
- •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
Nimotuzumab with radiotherapy
Patients will receive neoadjuvant radiotherapy with concurrent anti-PD-1 antibody SHR-1210. Radiation of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 40Gy/20f.
SHR-1210 200mg fixed dose every 2 weeks delivered concurrent with radiation therapy.
After 2-4 weeks of neoadjuvant treatment, patients will be evaluated by a multidisciplinary teams (MDTs) and esophagectomy will be given for patients with resectable disease.
干预措施: 3-DCRT or IMRT radiation (Radiation)
Nimotuzumab with radiotherapy
Patients will receive neoadjuvant radiotherapy with concurrent anti-PD-1 antibody SHR-1210. Radiation of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 40Gy/20f.
SHR-1210 200mg fixed dose every 2 weeks delivered concurrent with radiation therapy.
After 2-4 weeks of neoadjuvant treatment, patients will be evaluated by a multidisciplinary teams (MDTs) and esophagectomy will be given for patients with resectable disease.
干预措施: anti-PD-1 antibody SHR-1210 (Drug)
结局指标
主要结局
Pathologic Complete Response Rate
时间窗: 2-4 weeks after completion of radiotherapy
the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery
次要结局
- Disease-Free Survival(2 years)
- Numbers of adverse events and the degree of each adverse events according to the NCI CTCAE 4.0 criteria.(6 months)
研究者
Shixiu Wu
Professor
Hangzhou Cancer Hospital