A Study of Anti-PD-1 Antibody, Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- unacceptable toxicity
研究概览
简要总结
The purpose of this study is to test the the efficacy and safety of sintilimab in combination with chemoradiation before surgery for 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
- •Histologically or cytologically confirmed esophageal squamous carcinoma
- •18≤age≤75
- •ECOG PS is 0-1
- •TanyN+M0 or T3-4NanyM0 tumors
- •Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon
- •No prior chemotherapy,radiotherapy and immunotherapy
- •Disease must be clinically limited to the esophagus
- •No esophageal perforation and no active esophageal bleeding
- •No interstitial pneumonia or history of interstitial pneumonia
- •FEV1>1.2L
- •Adequate organ function defined at baseline as: WBC ≥3,000/ L，ANC ≥1,500/ L，Platelets ≥100,000/ L，Hb ≥9 g/dl； Calculated creatinine clearance >40 ml/min using Cockcroft-Gault method: Males: Creatinine CL = Weight (kg) x (140 - Age) . (mL/min) 72 x serum creatinine (mg/dL)Female：Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)；Total serum bilirubin ≤1.5 mg/dL， AST/ALT ≤2.5× upper limit of normal，Mean QT interval corrected for heart rate (QTc) <470 ms calculated from 3 ECGs using Frediricia's Correction
- •Able to provide written informed consent
- •Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
排除标准
- •Previous treatment with chemotherapy, radiotherapy or immunotherapy
- •Cervical esophageal cancer
- •Esophageal perforation or active esophageal bleeding
- •Interstitial pneumonia or history of interstitial pneumonia
- •Patients with evidence of metastatic disease
- •Chronic Hepatitis B or C infection (e.g. Hepatitis B surface Ag positive or detectable viral load for Hepatitis B or C). Patients with prior evidence of Hepatitis B or C without active infection are eligible
- •Autoimmune diseases (such as systemic lupus erythematosus, rheumatoid rthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next stage of screening: type I diabetes, skin diseases without systemic treatment (such as vitiligo, psoriasis)
- •14 days before the first dose, the patient had an active infection that required systemic treatment
- •Inability to understand or may not comply with test requirements
研究组 & 干预措施
arm
Biological: Sintilimab For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Drug: Paclitaxel 50 mg/m^2 IV Q3W day 1, day 8 and day 15
Drug: carboplatin AUC: 2 IV Q3W day 1, day 8 and day 15
Radiotherapy:
1.8 Gy/fraction ×23 fractions Monday to Friday total dose of 41.4 Gy
干预措施: Sintilimab (Biological)
arm
Biological: Sintilimab For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Drug: Paclitaxel 50 mg/m^2 IV Q3W day 1, day 8 and day 15
Drug: carboplatin AUC: 2 IV Q3W day 1, day 8 and day 15
Radiotherapy:
1.8 Gy/fraction ×23 fractions Monday to Friday total dose of 41.4 Gy
干预措施: carboplatin/paclitaxel (Drug)
arm
Biological: Sintilimab For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Drug: Paclitaxel 50 mg/m^2 IV Q3W day 1, day 8 and day 15
Drug: carboplatin AUC: 2 IV Q3W day 1, day 8 and day 15
Radiotherapy:
1.8 Gy/fraction ×23 fractions Monday to Friday total dose of 41.4 Gy
干预措施: Radiation (Radiation)
结局指标
主要结局
unacceptable toxicity
时间窗: 1 year
"Unacceptable toxicity" is defined as any of the following toxicities: \>1 episode of grade 3/4 neutropenia or thrombocytopenia \<75,000/μL (despite prior dose reduction) during chemoradiation any toxicity that results in \>2 week cumulative delay in chemoradiation any toxicity that is attributed to durvalumab which results in a delay of \>8 weeks in surgery, i.e. surgery \>16 weeks from the end of radiation, for a potentially operable patient any reason that is attributed to durvalumab which leads to death within 30 days of surgery
pathologic complete response rate, pCR
时间窗: 1 year
major pahological response, MPR
时间窗: 1 year
次要结局
未报告次要终点