NCT02557503Unknown4 期
An Randomized and Controlled Study of Hepatic Arterial Infusion of Oxaliplatin and Fluorouracil Treatment of Advanced Primary Liver Cancer After TACE
Zhu Xu1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
To investigate the therapy effect and security of oxaliplatin and fluorouracil on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer
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 liver cancer
- •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)
排除标准
- •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
研究组 & 干预措施
Oxaliplatin by HAIC after TACE
Experimental
To investigate the therapy effect and security of oxaliplatin on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer
干预措施: Oxaliplatin and fluorouracil (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
研究点 (1)
Loading locations...
相似试验
招募中
3 期
FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind TrialHepatocellular CarcinomaNCT06201065Sun Yat-sen University200
招募中
3 期
HAIC With One-day FOLFOX vs. HAIC With Two-day FOLFOX for Unresectable HCC: a Non-inferiority StudyHepatocellular CarcinomaNCT05476432Sun Yat-sen University300
Unknown
4 期
Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver MetastasesColon Cancer Liver MetastasisNCT02557490Zhu Xu100
已完成
2 期
TOF Versus SOX in Metastatic Gastric CancerGastric CancerNCT02442362The First People's Hospital of Changzhou60
撤回
2 期
FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal CancerMetastatic Colorectal CancerNCT04430985Dorte Nielsen