NCT05807542已完成2 期
Prediction for pCR After Neoadjuvant Immunotherapy Combined With Chemotherapy Using Single-Cell RNA Sequencing in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC) : A Single-Arm Phase II Clinical Trial
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pathological complete response
研究概览
简要总结
Prediction for pCR After Neoadjuvant Immunotherapy Combined With Chemotherapy Using Single-Cell RNA Sequencing in Patients With 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years ;
- •Initially diagnosed patients with stage T2-4aN0-1M0 esophageal squamous cell carcinoma;
- •No chemotherapy or any other antitumor therapy was used before inclusion
- •ECOG score 0-1;
- •Life expectancy is greater than 3 months;
- •The patient has no indication for emergency surgery；
- •No immediate childbearing requirement；
- •The main organs function well, and the examination indicators meet the following requirements:
- •i. Blood routine examination:
- •Hemoglobin ≥90 g/L (no blood transfusion within 14 days);
- •Neutrophil count ≥1.5×109/L;
- •Platelet count ≥75×109/L; ii. Biochemical examination: iii. Total bilirubin ≤1.5×ULN (upper limit of normal); iv. Serum alanine aminotransferase (ALT) or serum alanine oxalacetic aminotransferase (AST) ≤ 2.5×ULN; v. Endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula);
- •Sign informed consent;
- •The compliance was good, and the family members agreed to cooperate with the survival follow-up.
排除标准
- •Pregnant or nursing women；
- •Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and cervical carcinoma in situ；
- •Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as determined by the investigator, may prevent the signing of informed consent or affect the patient's adherence to medication use；
- •Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases；
- •Allergic to any investigational drug ingredient；
- •Any bleeding event with a severe grade of 3 or above CTCAE4.0 occurring within 4 weeks prior to screening;
- •Patients with hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg) who are not well controlled by single antihypertensive medication;History of unstable angina pectoris;Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening;Arrhythmias (including QTcF: male ≥450 ms) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade ≥II cardiac insufficiency;
- •Long-term unhealed wounds or incomplete healing fractures;
- •Previous history of organ transplantation;
- •Imaging shows that the tumor has invaded important blood vessels, or the investigator determines that the patient's tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment;
- •Patients with abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L) and bleeding tendency (14 days before randomization must meet the requirement that INR is within the normal range without the use of anticoagulants);Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogities;Low doses of warfarin (1 mg orally, once daily) or low doses of aspirin (up to 100 mg daily) are permitted for prophylactic purposes if INR ≤ 1.5;
- •Occurrence of arteriovenous thrombosis within one year prior to screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization during previous chemotherapy and determined to be cured by researchers), pulmonary embolism, etc.;
- •Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders;
- •A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- •In the investigator's judgment, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study.
- •Patients who did not meet the inclusion criteria, or who were considered unsuitable for the study by the investigator.
研究组 & 干预措施
Tislelizumab combined with chemotherapy
Experimental
干预措施: Tislelizumab (Drug)
Tislelizumab combined with chemotherapy
Experimental
干预措施: Paclitaxel-albumin (Drug)
Tislelizumab combined with chemotherapy
Experimental
干预措施: Carboplatin (Drug)
结局指标
主要结局
Pathological complete response
时间窗: 4 weeks after surgery
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
次要结局
- Major pathological response(4 weeks after surgery)
- Objective Response Rate (ORR)(At the end of Cycle 3 (each cycle is 21 days))
研究者
研究点 (1)
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