Evaluation the Potential of Colchicine for the Palliative Management of Hepatocellular Carcinoma Patients With Distant Metastasis or Large Vessel Invasion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This trial is to evaluate the potential of colchicine for the palliative management of hepatocellular carcinoma patients with distant metastasis or large vessel invasion using the Department of Health R.O.C. approved doses and methods of administration.
详细描述
Dosing schedule: 2 tablets (1 mg) three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle)
Adjustment the dosage of colchicine during study:
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The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according to the following rules.
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2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial
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If the hepatic reserved function of the participant returns to Child A, The dosage for Child A will be restored.
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If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.
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If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again according to the following rules.
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For participant receives﹝2 tablets after breakfast, 2 tablet after lunch and 2 tablets after dinner﹞, the dosage of colchicine will be changes to﹝2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner﹞.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Patient has at least one of the following criteria: (1) positive for hepatocellular carcinoma evidenced by cytology or pathology, (2) serum alpha-fetoprotein level > 400 ng/mL and has evidence of hepatocellular carcinoma provided by contrast-enhanced computed tomography or magnetic resonance imaging.
- •. Contrast-enhanced computed tomography or magnetic resonance imaging has evidence of distant metastasis or large vessel invasion caused by hepatocellular carcinoma.
- •. Patient has Child A hepatic reserved function
排除标准
- •. There are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.
- •. There are life-threatening bacterial, fungal or viral infection (not included hepatitis B and C virus).
- •. Patient has serum creatinine level > 1.5 mg/dL.
- •. Patient must receive long-term medication of statin or fibrates drugs and these medications can not be changed.
- •. Patient has white blood cell count < 1500/µL, platelet count < 30000/µL or hemoglobin < 9.0 gm/dL after medication.
- •. Pregnant woman or plan to be a pregnant woman
- •. allergy to colchicine or has history of severe side effects caused by colchicine
- •. Patient has received systemic chemotherapy within 2 months before enrollment or plans to receive systemic chemotherapy in the future.
- •. Patient is under or plans to receive Nexavar or other clinical trial testing drug.
- •. Patient has severe malfunction of vital organs and can not participate in this study justified by the doctor in this research team.
- •. Patient is under or plans to receive Chinese traditional medicine or herb drugs.
研究组 & 干预措施
colchicine treated patients
2 tablets (0.5 mg/tablet) of colchicine three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial
干预措施: Colchicine (Drug)
结局指标
主要结局
Overall Survival
时间窗: up to 72 months
The overall survival of the participants calculated from the date of enrollment to the date of death will be compared with the control group with the same TNM and the Barcelona Clinic Liver Cancer (BCLC) staging collected from 2005/1/1 to the end of this study. The overall survival of the control group was calculated from the date of receiving sorafenib treatment to the date of death.
次要结局
- Grade III Severe Adverse Events(up to 72 months)
研究者
Zu-Yau Lin
professor
Kaohsiung Medical University Chung-Ho Memorial Hospital