NCT06092242尚未招募2 期
The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer
The Second Affiliated Hospital of Shandong First Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月15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
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
To evaluate the efficacy and safety of TAS-102 combined with bevacizumab as first-line therapy in patients with advanced colorectal cancer who could not tolerate or did not receive combined chemotherapy
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Life expectancy of at least 3 months
- •Definitive histological or cytological evidence of adenocarcinoma of the colon or rectum;
- •Patients who had not previously received first-line chemotherapy or targeted therapy for metastatic colorectal cancer, or who had received adjuvant chemotherapy after radical resection and had relapsed 12 months after completion of adjuvant chemotherapy;
- •Patients who can not or can not tolerate combination chemotherapy.
- •ECOG performance status was PS ≤2;
- •According to RECIST Version 1.1, at least 1 measurable metastatic lesion was present;
- •Appropriate organ function according to laboratory test values obtained within 7 days prior to administration of the study drug on Day 1 of Cycle
- •A .The hemoglobin value was more than 90 g/L. B. The absolute neutrophil count was > 1.500 MM
- •C. Platelet count was > GT; 100,000/mm (> GT; 100 * 10 ° L) . D. Total serum bilirubin was 1.5 x upper limit of normal (ULN) . E.Don't L-aspartic Acid aminotransferase (asgot) and endolaminic aminotransferase (Alt SGPT)≤2.5 x upper limit of normal (ULN) , and AST and ALT ≤5 x ULN if abnormal liver function is due to basal liver metastasis.
- •F. Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance ≥50 ml/min;.
- •G.Adequate coagulation: international standard ratio (INR) or prothrombin time (PT)≤1.5 times the upper limit of normal;. Urine or serum pregnancy tests were negative within 7 days of randomization.
- •Women at risk of pregnancy must agree to use adequate contraception during the study until 6 months after the cessation of the study drug; Men had to agree to use adequate contraception during the study until six months after the study drug was discontinued.
- •Willing and able to follow research protocols and visit plans.
排除标准
- •The existence of serious diseases and serious medical conditions, this includes, but is not limited to, the following:
- •the presence of other active malignancies at the same time, excluding those that have not been diagnosed for more than 5 years or are considered curable with adequate treatment,
- •the known presence of brain or pial metastases,
- •systemic active infection (ie, infection leading to body temperature ≥38 ° C-RRB- ,
- •clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease,
- •uncontrolled diabetes;
- •patients who have experienced any arterial thrombosis, embolism, or ischemic or hemorrhagic disease in the last 6 months and have not improved after appropriate treatment, such as unstable myocardial infarction, unstable angina, cerebrovascular accident after treatment,
- •severe/unstable angina, NYHA Class III or IV symptomatic congestive heart failure,
- •clinically significant gastrointestinal bleeding,
- •known presence of human immunodeficiency virus (HIV) or acquired conventional immunodeficiency syndrome (AIDS)-related disease, or active hepatitis B or C,
- •presence of psychiatric disorders that may increase the risk of participating in the study or taking research drugs, or that may interfere with the interpretation of the study results;
- •patients with grade 2 or more hypertension before treatment who had not improved or were unstable with antihypertensive drugs,
- •patients with nephrotic syndrome or with proteinuria ≥2 + or more before treatment who had not improved or were unstable after treatment, 13-RRB- patients with a history of gastrointestinal perforation in the last 6 months,
- •patients with Hypertensive crisis hypertensive encephalopathy. 2.Any of the following treatments were performed within a specific time frame prior to study drug administration,
- •1）major surgery (laparotomy, thoracotomy, and evisceration by laparoscopy) was performed within the previous 4 weeks. Switch surgery was not included) ; 2) had received extended-range radiotherapy within the previous 4 weeks or had received limited-range radiotherapy within the previous 2 weeks; 3) had received any investigational medication within the previous 4 weeks.
- •Neurotoxicity of CTCAE grade 2 or above that has not subsided as a result of adjuvant therapy,
- •A pregnant or lactating woman.
- •The researchers did not consider it appropriate to enter the study.
研究组 & 干预措施
TAS-102 combined with bevacizumab
Experimental
干预措施: Tas-102(Suyuan) combined with bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 2 years
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
次要结局
- Overall Survival(3 year)
- Objective Response Rate(2 year)
- Quality of life score(3 year)
研究者
研究点 (1)
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