NCT07266493招募中2 期
A Single-arm, Open-label, Single-center Prospective Study of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年12月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate
研究概览
简要总结
This single center, prospective, single arm clinical study aims to evaluate the clinical efficacy and safety of Envafolimab combined with albumin bound paclitaxel and carboplatin as neoadjuvant therapy for 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects voluntarily joined this study, were able to sign the informed consent form, and had good compliance;
- •Age ≥ 18 years old (when signing the informed consent form);
- •ECOG score 0-1 points;
- •Diagnosed with operable esophageal squamous cell carcinoma through pathological diagnosis (pathological tissue/cytology) and imaging;
- •The clinical TNM staging is T2-4aNxM0
- •Patients assessed to require routine neoadjuvant therapy;
- •Have not received immunotherapy, chemotherapy, targeted therapy, or radiotherapy in the past;
- •Expected survival ≥ 12 weeks
排除标准
- •The subjects have any active autoimmune diseases or a history of autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, thyroid dysfunction (hyperthyroidism/hypothyroidism), and the use of drugs cannot maintain thyroid function within the normal range, or patients who have undergone thyroid surgery and require long-term replacement therapy with thyroid hormone and other drugs after surgery); Subjects with vitiligo or complete remission of childhood asthma who do not require any intervention in adulthood may be included; Asthma in which subjects require bronchodilators for medical intervention cannot be included
- •The subject has previous or concurrent malignant tumors;
- •Patients who have received systemic anti-tumor therapy in the past;
- •Individuals who have undergone significant surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of treatment; Or there may be wounds or fractures that have not been cured for a long time;
- •There is a risk of bleeding, coagulation dysfunction, or currently undergoing thrombolytic therapy; Or have experienced esophageal or gastric variceal rupture bleeding in the past 6 months;
- •It is known that the subject has a history of allergies to large molecule protein preparations or drug ingredients used;
- •Subjects with any severe and/or uncontrolled illnesses
- •Ascites or pleural effusion with clinical symptoms cannot be controlled with medication and require therapeutic puncture or drainage;
- •The subject is known to have a history of substance abuse, alcoholism, or drug use;
- •The researchers believe that participants should be excluded from this study, for example, if the researchers determine that there are other factors that may cause the study to be terminated midway
研究组 & 干预措施
Experimental: Envafolimab+Chemotherapy Group（EC Group）
Experimental
Envafolimab: 150mg, subcutaneous injection, administered on days 1, 8, and 15, treated for 3 weeks, followed by a 1-week rest period; Albumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period. All patients will receive treatment with Envafolimab combined with albumin bound paclitaxel and carboplatin for three weeks, followed by one week of rest and a 28 day treatment cycle, for a total of two cycles. Then, the tumor condition of the patients will be evaluated to determine whether surgical treatment is feasible.
干预措施: Chemotherapy （Albumin bound paclitaxel and Carboplatin） (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate
时间窗: From enrollment to the end of treatment at 8 weeks
次要结局
- R0 resection rate(From enrollment to the end of treatment at 10 weeks)
- Major pathological response rate(From enrollment to the end of treatment at 8 weeks)
- ORR(From enrollment to the end of Cycle 2 (each cycle is 28 days))
- 3y-RFS rate(From enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 36 months)
- 3y-OS rate(From enrollment until the date of death from any cause, assessed up to 36 months)
研究者
Ge Di
Ge Di., MD
Shanghai Zhongshan Hospital
研究点 (1)
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