Safety and Efficacy of Combination of Sintilimab and Platinum-based Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer: An Open-lable, Single-arm, Exploratory Clinical Study
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and feasibility
研究概览
简要总结
This study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer.
详细描述
This study was designed as an open-lable, single-arm, exploratory clinical study. Sintilimab in combination with liposomal paclitaxel, cisplatin and S-1 will be given every 3 weeks to our patients for 2 cycles as neoadjuvant therapy. A radical dissection is scheduled within 6 weeks after last neoadjuvant treatment. This study will be devided for 3 phases: safety run-in, efficacy pilot and efficacy confirmation.
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 70 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 cell carcinoma.
- •The tumor is located in the middle or lower third of the esophagus ( more than 18cm below incisor), potentially resectable and requiring neoadjuvant therapy (T1b-3, Nany, M0 or T4a, N0-1, M0).
- •No prior treatment for this disease.
- •Eastern cooperative oncology group (ECOG) performance status of 0 to
- •Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol.
- •Understand and voluntarily sign the informed consent(s).
- •Patients who are able to complete the treatment and follow-up according to the study plan.
- •Patients who have sufficient tissue samples and agree to provide their tissue samples and blood samples for detailed analysis.
- •Female patients in child bearing period must have evidence of negative pregnancy test and agree to take effective contraceptive measures during the study.
排除标准
- •Patients who may develop tracheoesophageal fistula or aortoesophageal fistula.
- •Patients suffering from severe malnutrition or needing tube feeding.
- •Uncured patients with other malignancies within 2 years.
- •Patients who have active autoimmune diseases or patients who are undergoing treatment of autoimmune diseases.
- •Patients who need systemic glucocorticosteroid treatment (more than 10mg prednisone daily or other equivalent drugs) within 7 days before the neoadjuvant therapy or other immunosuppressive drugs.
- •Patients who have immune deficiency.
- •Patients with active viral or bacterial infection who need systemic treatment within 7 days before the neoadjuvant therapy.
- •Patients with uncontrolled diabetes mellitus.
- •Patients with interstitial pulmonary disease, noninfectious pneumonia, or pulmonary fibrosis.
- •Patients with preexisting symptoms of sensory or motor nerve damage (greater than Grade 1, WHO) .
- •Patients who have received allogeneic organ or stem cell transplants.
- •Patients who are allergic to drugs or related ingredients in this study.
- •Patients who take part in clinical trials of other drugs or biological therapy at present.
- •Patients with any serious or unstable medical condition or mental illness.
- •Patients who are dependent on or addicted to alcohol or drugs.
研究组 & 干预措施
Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1
Sintilimab will be administered prior to the chemotherapy in an interval of half an hour.
干预措施: Sintilimab (Drug)
Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1
Sintilimab will be administered prior to the chemotherapy in an interval of half an hour.
干预措施: Liposomal Paclitaxel + Cisplatin + S-1 (Drug)
结局指标
主要结局
Safety and feasibility
时间窗: 20 months
Safety is defined as the incidence of Grade 3-4 Treatment-Related Adverse Events (TRAEs) from the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. Feasibility of surgery is defined as the incidence of TRAEs causing surgery delay of ≥30 days and/or inoperable patients.
次要结局
- Recurrence-Free Survival (RFS)(5 years)
- Overall Survival (OS)(5 years)
- R0 resection rate(20 months)
- MPR rate(20 months)
研究者
Gu Yanhong
Prof.
The First Affiliated Hospital with Nanjing Medical University