Neoadjuvant Immunotherapy Plus Chemotherapy and Anlotinib Versus Immunotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced ESCC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR), Major pathological response (MPR)
研究概览
简要总结
The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.
详细描述
The goal of this single-center, open-label, non-inferior, randomized controlled, interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgically resectable cT1-4aN+M0 or cT3-4aN0M0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology
- •Patients who can take anlotinib capsules orally
- •No previous systematic antitumor treatment
- •ECOG PS 0-1
- •The function of important organs meets the following requirements: absolute neutrophil count≥1.5×10^9 / L; platelet≥80×10^9 / L; hemoglobin≥80×10^9 / L; total bilirubin≤1.5×upper limit of normal; within normal serum creatinine; ALT and glutamatergic aminase≤2.5× upper limit of normal
- •No incurable serious complications or other major diseases
- •The thoracic surgeon judges that the operation can be tolerated
- •Female subjects with fertility, and male subjects with childbearing partners, required a medically approved contraceptive during study treatment and at least 6 months after the last chemotherapy
- •The subjects volunteered to join the study, signed informed consent, had good compliance and cooperated with follow-up
排除标准
- •BMI<18.5kg/m2 or 10% weight loss in 2 months before screening (while considering the effect of large chest ascites on body weight)
- •Patients with tracheal / bronchial / macrovascular invasion, deep ulcer esophagus, digestive tract perforation and / or fistula, major bleeding, and poor lung function or previous chronic lung disease within 6 months prior to initial medication
- •Patients with significant feeding obstruction unable to take oral anlotinib
- •Known history of allergy to any component of biological or PD-1 mab formulation, albumin-bound paclitaxel, carboplatin and other platinum drugs manufactured by Chinese hamster ovary cells (CHO)
- •Have received any of the following treatments: any investigational drug; enrolled in another clinical study except for an observational (non-interventional) clinical study; received anti-tumor or live vaccine
- •A history of active autoimmune diseases and autoimmune diseases
- •A history of immunodeficiency, including a positive HIV test, or other acquired, congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation
- •The subject had cardiovascular clinical symptoms or disease that were not well controlled
- •Patients with active hepatitis B or hepatitis C and active pulmonary tuberculosis
- •Severe infection (CTCAE> 2) occurred within 4 weeks prior to initial use of study drug, such as severe pneumonia, bacteremia, infection requiring hospitalization; baseline chest imaging indicated active lung inflammation, symptoms and signs of infection within 2 weeks prior to initial use of study drug or the need for oral or intravenous antibiotics, except for prophylactic antibiotics
- •Major surgery (except diagnostic surgery) within 28 days prior to treatment, or is expected to undergo major surgery during the study
- •Any other malignancy had been diagnosed within 5 years prior to the first use of study drug, except for nausea tumors with low risk and mortality (5-year survival> 90%), such as adequately treated basal or squamous cell skin carcinoma or carcinoma of the cervix
- •Female patients during pregnancy or lactation and who were refused or unable to use contraception
- •At the discretion of the investigator, the subject had other factors that could contribute to his forced termination
研究组 & 干预措施
neoadjuvant immunotherapy plus chemotherapy and anlotinib
neoadjuvant immunotherapy plus chemotherapy and anlotinib
干预措施: Thoracic radiotherapy (Radiation)
neoadjuvant immunotherapy combined with concurrent chemoradiotherapy
neoadjuvant immunotherapy combined with concurrent chemoradiotherapy
干预措施: anlotinib (Drug)
结局指标
主要结局
Pathological complete response (pCR), Major pathological response (MPR)
时间窗: Up to approximately 15 weeks after randomization
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes
Major pathological response (MPR)
时间窗: Up to approximately 15 weeks after randomization
Major pathological response (MPR)
次要结局
- 3-year disease free survival(From date of randomization to approximately 3 years after date of resection)
- Objective response rate (ORR)(Up to approximately 15 weeks after randomization)
- R0 excision rate(Up to approximately 15 weeks after randomization)
- 3-year overall survival(From date of randomization to approximately 3 years after date of resection)
研究者
Mengxia Li
Department of Cancer Center, Army Medical Center of PLA
Army Medical Center of PLA