NCT05381636Unknown2 期
Esophageal Arterial Infusion Chemotherapy Versus Systemic Intravenous Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Prospective, Multicentre, Randomised Controlled Clinical Study
The First Affiliated Hospital of Zhengzhou University0 个研究点目标入组 120 人开始时间: 2022年6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
- 发起方
- 入组人数
- 120
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This was a prospective, multicentre, randomised controlled clinical study to explore the safety and efficacy of esophageal arterial infusion chemotherapy in patients with resectable locally advanced oesophageal cancer, and to compare its safety and efficacy with systemic intravenous chemotherapy. The rate of surgical R0 resection as well as progression free survival (PFS) were the main indicators.
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
- •Sign written informed consent prior to the implementation of any test related procedures;
- •Aged 18-75 years;
- •Histopathological examination confirmed resectable esophageal carcinoma (histologically, squamous cell carcinoma), without esophageal/gastric junction adenocarcinoma;
- •Before surgery, CT/MRI, color ultrasound, PET-CT, and ultrasonic gastroscopy were used to clearly diagnose esophageal cancer staging as >= CT3 or >=N+;
- •Newly diagnosed patients without previous surgery, radiotherapy or chemotherapy, targeted therapy or immunotherapy;
- •ECOG score ≤2，KPS ≥60%;
- •No serious heart, lung or liver dysfunction; No acute infection was associated;
- •No participation in other clinical studies within 3 months prior to treatment;
- •Sufficient organ function, subject should meet the following laboratory criteria:
- •The absolute value of neutrophils (ANC) ≥1.5x10^9/L in the last 14 days without the use of granulocyte colony-stimulating factor;
- •Platelets ≥80x10^9/L in the case of no blood transfusion in the last 14 days;
- •Hemoglobin ≥80g/dL in the absence of blood transfusion or use of erythropoietin in the last 14 days;
- •Total bilirubin ≤1.5 ULN; Or total bilirubin >ULN but direct bilirubin ≤ULN;
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ULN (ALT or AST≤5 ULN are allowed in patients with liver metastasis);
- •Serum creatinine ≤1.5 ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥60ml/min;
- •Good coagulation function, defined as INR or prothrombin time (PT) ≤1.5 ULN;
- •Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is beyond the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can be included;
- •Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judged that it is a simple laboratory abnormality without clinical significance, it is also allowed to be enrolled);
- •For female subjects of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (cycle 1 day 1). If a urine pregnancy test cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age were defined as at least 1 year postmenopausal or having undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects (both men and women) should use contraceptives with an annual failure rate of less than 1% throughout the treatment period and up to 1 year after the last study dosing.
排除标准
- •Previous operation history of thoracic malignant tumor;
- •Pathologically small cell carcinoma or distant metastasis; Patients with tumor involvement of the cervical esophagus or high upper thoracic segment requiring laryngectomy;
- •Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg);
- •Patients at high risk of bleeding or perforation due to tumor invasion of an adjacent organ of the esophageal lesion (aorta or trachea), or patients with fistula;
- •Other malignant diseases other than esophageal cancer diagnosed within 5 years prior to initial administration (excluding basal cell carcinoma of the skin after radical resection, squamous carcinoma of the skin, and/or carcinoma in situ after radical resection);
- •Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration;
- •Received Chinese patent drugs with anti-tumor indications or immunoregulatory drugs (including thymopeptide, interferon and interleukin, except for local use of pleural effusion control) within 2 weeks before the first administration;
- •Known interstitial pulmonary disease requiring steroid therapy, active pulmonary tuberculosis, active autoimmune disease requiring systemic therapy (e.g., use of palliative drugs, glucocorticoids, or immunosuppressants) developed within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment;
- •The study was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days prior to initial administration; Note: Physiological dose of glucocorticoids (≤10mg/ day of prednisone or equivalent drug) is allowed;
- •Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- •People who are known to be allergic to the active ingredients or exciphers of the drugs in this study, such as cisplatin, cisplatin, or albu-paclitaxel;
- •A known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive);
- •The presence of any serious or uncontrollable systemic disease, such as:
- •There are significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram with serious symptoms that are difficult to control, such as complete left bundle branch block, heart block above II degree, ventricular arrhythmia or atrial fibrillation;
- •Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥2 chronic heart failure;
- •Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before inclusion;
- •A history of non-infectious pneumonia requiring glucocorticoid therapy or current clinically active interstitial lung disease within 1 year prior to initial administration;
- •active tuberculosis;
- •the presence of active or uncontrolled infections requiring systemic treatment;
- •Clinical active diverticulitis, abdominal abscess and gastrointestinal obstruction;
- •Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- •Poor control of diabetes mellitus (FBG > 14mmol/L);
- •Routine urine indicated urinary protein ≥++, and confirmed 24-hour urinary protein quantitative > 1.0g;
- •Patients with mental disorders who are unable to cooperate with treatment; Medical history or evidence of disease that may interfere with the outcome of the study, prevent participants from participating in the study, abnormal therapeutic or laboratory test values, or other conditions that the investigator considers unsuitable for inclusion.
研究组 & 干预措施
Control group
Active Comparator
Systemic intravenous chemotherapy with albumin paclitaxel 125 mg / m2 for D1, D8 + cisplatin 75 mg / m2 for D1, every 3 weeks for 1 cycle
干预措施: Systemic intravenous chemotherapy (Drug)
Study group
Experimental
esophageal arterial infusion chemotherapy
干预措施: Esophageal arterial infusion chemotherapy (Procedure)
结局指标
主要结局
Progression free survival (PFS)
时间窗: up to 1 year
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Surgical R0 resection rate
时间窗: up to 1 year
次要结局
- Pathological complete response rate(PCRR)(up to 1 year)
- Objective response rate(ORR)(up to 1 year)
- Treatment related AES(up to 1 year)
- Overall survival (OS)(up to 1 year)
研究者
Gang Wu
Chief physician
The First Affiliated Hospital of Zhengzhou University
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