A Clinical Randomized Control Trial of Combination TACE With and Without Low-molecular-weight Heparin in Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- time-to-progression(TTP)
研究概览
简要总结
Hepatocellular carcinoma (HCC) is a major tumor type worldwide, especially in China as the sequence of hepatitis B and liver cirrhosis. Activation of the coagulation system occurs commonly in patients with malignancy. Several studies have suggested that anticoagulant therapy may improve survival in patients with malignancy. The low molecular weight heparins (LMWHs) lend themselves to such studies because of their effects in experimental models of malignancy and the relative ease of administration compared with unfractionated heparin. The purpose of the present RCT was to determine whether addition of LMWH to transarterial chemoembolization (TACE) would improve HCC patient outcome compared with TACE alone.
详细描述
100 patients will be randomly assigned to receive either TACE alone or TACE plus LMWH. A block of every 4 participants and a stratified randomization according to portal vein cancer emboli will be used to restrict randomization. LMWH consisted of nadroparin Ca will be given at a dose of 4100 U twice daily during 6 weeks after TACE. The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of LMWH on HCC.
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
- Single (Outcomes Assessor)
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
- •Adults patients with a diagnosis of HCC which is not amenable to surgical resection, liver transplantation or local ablative therapy
- •Without metastasis out of liver
- •Patients must have at least one tumor lesion that meets both of the following criteria:
- •The lesion can be accurately measured in at least one dimension according to RECIST criteria
- •The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
- •ECOG performance status (PS) <2
- •No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
- •Child-Pugh class A or B
- •No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
- •Ability to understand the protocol and to agree to and sign a written informed consent document -
排除标准
- •HBSAg(-)，AFP(-).
- •prothrombin time prolonged more than 4s.
- •blood platelets count less than 50000/L.
- •Renal failure requiring dialysis.
- •Child-Pugh class C hepatic impairment.
- •clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •History of organ allograft.
- •Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- •Pregnant or breast-feeding patients.
研究组 & 干预措施
TACE alone
50 HCC patients randomly assigned to receive TACE without LMWH
干预措施: LMWH (Drug)
TACE alone
50 HCC patients randomly assigned to receive TACE without LMWH
干预措施: TACE (Procedure)
LMWH plus TACE
50 HCC patients will be allocated to receive Nadroparin 4100 AXa iu twice daily 3 days after TACE which lasted for 6 weeks
干预措施: TACE (Procedure)
LMWH plus TACE
50 HCC patients will be allocated to receive Nadroparin 4100 AXa iu twice daily 3 days after TACE which lasted for 6 weeks
干预措施: LMWH (Drug)
结局指标
主要结局
time-to-progression(TTP)
时间窗: 1 year
次要结局
- The overall response rate(1 year)
- bleeding complication rate(6 weeks)
- Overall survival (OS)(1 year)
- Progression Free Survival (PFS)(1 year)
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospotal
Eastern Hepatobiliary Surgery Hospital