NCT05043688招募中3 期
Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy Alone for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NICE 2): a Multi-center, Randomized Phase II Trial
Zhigang Li5 个研究点 分布在 1 个国家目标入组 426 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 426
- 试验地点
- 5
- 主要终点
- EFS assessed by the investigator according to RECIST 1.1
研究概览
简要总结
The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.
详细描述
This study aimed to evaluate the efficacy and safety of adding immunotherapy to neoadjuvant chemotherapy (CT) or chemoradiotherapy (CRT) compared to neoadjuvant CRT alone for resectable locally advanced esophageal squamous cell carcinoma (ESCC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •The result of pathological biopsy showed esophageal squamous cell carcinoma;
- •Have not received systemic or local treatment for esophageal cancer in the past;
- •Age 18-75 years (including 18 and 75 years old), both male and female;
- •ECOG score 0-1;
- •Thoracic esophageal cancer assessed by CT/MRI/PET-CT etc. as resectable and the clinical stage is T1b-3N1-3M0 or T3N0M0, according to the 8th edition of AJCC staging;
- •Those who are expected to achieve R0 resection;
- •Voluntarily sign an informed consent form before treatment;
- •Plan to receive surgical treatment after neoadjuvant treatment is completed;
- •No surgical contraindications;
- •Normal function of major organs
- •Female subjects with fertility must undergo a serum pregnancy test within 72 hours before starting the study drug administration, and the result is negative, and take effective contraception during the trial and at least 3 months after the last administration Measures (such as intrauterine devices, contraceptives, or condoms); for male subjects whose partners are females of childbearing age, effective contraceptive measures should be taken during the trial and within 3 months after the last administration;
- •The subjects have good compliance and can follow up the efficacy and adverse events/reactions according to the requirements of the plan;
排除标准
- •There are unresectable factors, including unresectable tumors, unresectable contraindications for surgery, or rejection of surgery;
- •Patients with supraclavicular lymph node metastasis;
- •Poor nutritional status, BMI <18.5 Kg/m2; if the symptomatic nutritional support is corrected before randomization, the main investigator can continue to consider it after evaluation;
- •Those who are known to have a history of allergies to the drug components of this program;
- •Have received or are receiving any of the following treatments in the past:
- •Any radiotherapy, chemotherapy or other anti-tumor drugs for tumors;
- •Immunosuppressive drugs or systemic hormone drugs are being used within 2 weeks before the first use of the study drug to achieve immunosuppressive purposes (dose>10mg/day prednisone or equivalent dose); if there is no active autoimmune disease In the case of inhalation or topical use of steroids and prednisone doses> 10 mg/day or equivalent doses of adrenal cortex hormone replacement are allowed;
- •Received a live attenuated vaccine within 4 weeks before using the study drug for the first time;
- •Have undergone major surgery or severe trauma within 4 weeks before using the study drug for the first time;
- •A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
- •There are clinical symptoms or diseases of the heart that are not well controlled;
- •Severe infections (CTCAE v5.0> level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest activity Pulmonary inflammation, symptoms and signs of infection in the 14 days before the first use of the study drug, or those who require oral or intravenous antibiotic treatment, except for the prophylactic use of antibiotics;
- •Participated in other drug clinical studies within 4 weeks before randomization;
- •People who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy, or have other pulmonary fibrosis that may interfere with the judgment and management of immune-related lung toxicity , Organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects whose CT shows active pneumonia or severe lung dysfunction during the screening period; active tuberculosis;
- •Patients with any active autoimmune diseases or history of autoimmune diseases with the possibility of recurrence; patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, hair loss, and insulin treatment Patients with controllable type I diabetes or a history of asthma, but who have been completely relieved during childhood without any intervention can be included in the group; patients with asthma who need bronchodilator intervention cannot be included in the group;
- •There is active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of the analytical method);
- •Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, unless malignant tumors with low risk of metastasis or death (5-year survival rate> 90%), such as fully treated skin basal cell carcinoma or squamous cell Skin cancer or cervical carcinoma in situ, etc., may be considered for inclusion;
- •Women who are pregnant or breastfeeding;
- •According to the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as suffering from other serious diseases (including mental illness) requiring combined treatment, alcoholism, drug abuse, family or social factors, which may affect the subjects Factors of safety or compliance.
研究组 & 干预措施
Neoadjuvant Chemotherapy With Camrelizumab
Experimental
Chemotherapy: Paclitaxel（Albumin Bound）100mg/m2, Day 1,8,15，Carboplatin AUC=5mg/ml/min, Day 1； Camrelizumab: Day 1, every 3 weeks, 2 cycles; Postoperative adjuvant treatment: Camrelizumab maintenance
干预措施: Camrelizumab (Drug)
Neoadjuvant Radiochemotherapy With Camrelizumab
Experimental
Chemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29，Carboplatin AUC=2mg/ml/min，Day 1,8,15,22,29 Camrelizumab: 200mg，Day 1,22 Radiotherapy: 41.4 Gy , D1-5/W Postoperative adjuvant treatment：Camrelizumab maintenance
干预措施: Camrelizumab (Drug)
Neoadjuvant Radiochemotherapy With Camrelizumab
Experimental
Chemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29，Carboplatin AUC=2mg/ml/min，Day 1,8,15,22,29 Camrelizumab: 200mg，Day 1,22 Radiotherapy: 41.4 Gy , D1-5/W Postoperative adjuvant treatment：Camrelizumab maintenance
干预措施: radiotherapy (Radiation)
Neoadjuvant Radiochemotherapy
Active Comparator
Chemotherapy: Paclitaxel 50mg/m2, Day 1,8,15,22,29，Carboplatin AUC=2mg/ml/min，Day 1,8,15,22,29 Radiotherapy：41.4 Gy , D1-5/W. Postoperative adjuvant treatment: non-pCR: Camrelizumab maintenance; PCR: surveillance
干预措施: radiotherapy (Radiation)
结局指标
主要结局
EFS assessed by the investigator according to RECIST 1.1
时间窗: median EFS approximately over 45 months
defined as event free survival,defined as the time from randomization to the occurrence of tumor progression/recurrence /death, whichever comes first
次要结局
- OS(median OS approximately over 80 months)
- R0 resection rate(within 28 working days after surgery)
- DFS(median DFS approximately over 40 months)
- HRQoL(approximately 48 months)
- pCR(within 28 working days after surgery)
- MPR(within 28 working days after surgery)
- Adverse events (AEs)(through study completion, assessed up to 50 months)
研究者
Zhigang Li
chief physician
Shanghai Chest Hospital
研究点 (5)
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