NCT05340231尚未招募2 期
An Exploratory Study of Sequential Transarterial Chemoembolization With Lipiodol and Neoadjuvant Chemotherapy in the Treatment of Initial Unresectable Colorectal Cancer
Gang Wu0 个研究点目标入组 100 人开始时间: 2022年5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
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- PFS
研究概览
简要总结
This is a prospective, open-labelled study to evaluate the efficacy and safety of sequetial transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable colorectal cancer. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;
- •Aged >=18 years, <= 85 years;
- •Histologically confirmed initial unresectable colorectal cancer;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •Expected survival period ≥ 3 months;
- •At least one measurable lesion, according to RECIST 1.1;
- •The main function is normal.
排除标准
- •Known hypersensitivity to any of the study drugs or excipients;
- •Hypertension that is not controlled by the drug;
- •International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
- •WBC count < 3000 /mm^3;
- •Platlet count < 50000 /mm^3;
- •Poorly controlled diabetes before enrollment;
- •Clinically significant electrolyte abnormalities judged by researchers;
- •Patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment;
- •Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%;
- •Active infection or serious infection that is not controlled by drug;
- •History of clinically significant hepatic disease (ALT and/or AST >5 times the upper normal limit);
- •Women who are pregnant or lactating;
- •Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
- •Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.
研究组 & 干预措施
Study group
Experimental
sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy
干预措施: TACE protocol (Drug)
Control group
Active Comparator
neoadjuvant chemotherapy alone
干预措施: Neoadjuvant Chemotherapy (Drug)
结局指标
主要结局
PFS
时间窗: up to 3 years
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
次要结局
- ORR(up to 3 years)
- Overall survival (OS)(up to 3 years)
- Pathological response rate (PCR+MPR)(up to 3 years)
研究者
Gang Wu
Chief physician
The First Affiliated Hospital of Zhengzhou University
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