A Randomized Controlled Trial of TACE Hepatic Artery Infusion of Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study was a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion
详细描述
Colorectal cancer is one of the most common malignancies, with 1 million new cases and half a million deaths each year worldwide. The development of metastases is the main cause of death. Liver metastases are diagnosed in 10-25% of patients at the time of resection of their primary colorectal tumor and, eventually, up to 70% of patients with colorectal cancer develop liver metastases.Oxaliplatin and raltitrexed were used for the treatment of colorectal cancer with liver metastases. We aimed to perform a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion.
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
- •With written informed consent
- •Age ranged from 18 to 80 years, both men and women
- •Confirmed by pathology or clinical diagnosis of unresectable colorectal cancer with liver metastases patients(including the primary tumor and liver in patients with brain metastases except outside of metastasis in patients with unresectable)
- •Progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy
- •Never received TACE treatment
- •(M) RECIST 1.0 criteria measurable liver lesions at several ≥2, each lesion diameter ≥3 cm long and ≤20cm,
- •ECOG PS score of ≤2
- •expected survival time ≥12 weeks
- •The test results before 7 days entered the group must meet the following requirements:
- •Hemoglobin ≥ 90 g / L
- •Absolute neutrophil count (ANC)> 1,500 / mm3
- •Platelet count ≥ 80x109 / L
- •Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 times the upper limit of normal (UNL)
- •Total bilirubin <3UNL
- •Serum creatinine <1.5 UNL
- •PT or INR, PPT <1.5 UNL (for patients undergoing warfarin or heparin anticoagulant therapy, if there is no evidence that there is an abnormality of the above parameters, you can enter the group, but must be closely monitored to detect at least once a week until the INR stable)
- •Exclusion criteria
- •Specific circumstances of patients not suitable for TACE therapy / chemotherapy
- •Hepatic decompensation, or the presence of hepatic encephalopathy
- •Before entering the study with gastrointestinal bleeding within 30 days
- •Presence of brain metastasis
- •Pregnant or lactating women
- •Active bleeding or sepsis
- •History of heart disease:
- •NYHA two or more of congestive heart failure, symptomatic coronary artery disease
- •Need to use β-blockers or digoxin medication other than arrhythmias
- •Despite treatment, still systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg hypertension
- •Not cure severe trauma, acute or incurable ulcer, or three months fracture
- •The researchers believe their poor compliance
- •Exist once or primary lesion or histologically different tumors and colorectal cancer, except: head and neck carcinoma in situ, cured basal cell carcinoma, superficial bladder cancer (Ta, Tis, T1), and the group 3 years ago, it has been cured of cancer
- •HIV infection or the presence of AIDS-related illness, or severe acute and chronic diseases
- •Drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders
- •Need drug therapy epilepsy (such as steroids or antiepileptic drugs
- •Chemotherapy contraindications exist
- •Any instability or likely to endanger the patient in this study the safety and compliance of the case
排除标准
- 未提供
研究组 & 干预措施
Oxaliplatin by TACE
Oxaliplatin for the therapy of Colorectal Cancer With Liver Metastases by TACE.No interventions was raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE.
干预措施: oxaliplatin and raltitrexed (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: three years
次要结局
- overall survival (OS)(three years)
研究者
Zhu Xu
Interventional Therapy Department
Peking University Cancer Hospital & Institute