Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- survival
研究概览
简要总结
This trial is to evaluate the palliative effects of colchicine on primary hepatic malignancy using the Department of Health R.O.C. approved doses and methods of administration. Colchicine will be started from 2 tablets after meal twice per day (total 2 mg), adjust the dose ranging from total minimum 1.5 mg to maximum 3 mg per day based on the condition and tolerance of the participant. One cycle of treatment is defined as 4 days treatment and 3 days off. The participants will receive repeated treatment cycles till the participants quit the trial. The control group will be originated from review of (1) patients treated by members of this research team with the same condition as the trial selected participants but not included in the trial, (2) patients with same condition as the trial selected participants reported in the literatures. The primary objective is to evaluate the palliative effects of colchicine on primary hepatic malignancy unable to receive curative treatment. The primary end point is survival of the participant. The Secondary objective is to evaluate the safety of patients treated by colchicine and the secondary end point is the side effects of colchicine.
详细描述
Study procedures
- Written informed consent before study specific procedures are undertaken. The investigators will explain the contents of the trial especially the information about the possible side effects, other alternative treatment and the right to withdraw based on the participant own willing to the candidates. Patient can choose to sign or not to sign the inform consent based on his/her own decision after completely understanding the investigators explanation.
- The process of the experiment
Start to receive colchicine:
Participant will start to receive colchicine starting from 2 tablets after meal twice per day (total 2 mg).
Adjustment the dosage of colchicine during study: based on the following steps:
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(A). Primary hepatic malignancy including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, hepatocellular-cholangiocarcinoma, poorly differentiated or undifferentiated primary hepatic malignancy.
- •Diagnosis of hepatocellular carcinoma: 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 on contrast-enhanced computed tomography or magnetic resonance imaging.
- •Diagnosis of intrahepatic cholangiocarcinoma: Patient has at least one of the following criteria: (1) evidenced by cytology or pathology, (2) serum CA19-9 level > 10 times of normal upper limit and has evidence on contrast-enhanced computed tomography or magnetic resonance imaging, and no evidence of extrahepatic original malignancy.
- •Diagnosis of hepatocellular-cholangiocarcinoma: concomitantly fit at least one of the items described in (a) and (b)
- •Diagnosis of poorly differentiated or undifferentiated primary hepatic malignancy: Patient fits all of the following criteria: (1) evidenced of malignancy other than hepatocellular carcinoma, intrahepatic cholangiocarcinoma or hepatocellular-cholangiocarcinoma by cytology or pathology, (2) no evidence of extrahepatic original malignancy
- •(B). Primary hepatic malignant tumors unable to receive curative treatment indicate that the malignancy can not be completely eliminated by operative resection, liver transplantation or local abrasion therapy. Patient also needs to fit at least one of the following criteria: (1) evidence of distant metastasis or large vessels (intrahepatic first branch portal vein, portal main trunk, major hepatic vein or inferior vena cava) invasion, (2) unable to be controlled by transcatheter arterial chemoembolization including appearance of new rather than incompletely treated nodules within 3 months of chemoembolization, or chemoembolization fails
- •(C). The performance status of the patient based on the Eastern Cooperative Oncology Group (ECOG) belongs to 0 or 1 and the calculated Child score is below 8 points.
排除标准
- •. life-threatening hemorrhage at the present time
- •. life-threatening bacterial, fungal or viral infection (not included hepatitis B and C virus) at the present time
- •. extrahepatic original malignancy unable to be controlled
- •. serum creatinine level > 1.5 mg/dL.
- •. Patient must receive long-term statin or fibrates drugs. The doses of these medications can not be altered.
- •. 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 other clinical trial testing drug.
- •. Patient has severe malfunction of vital organs and can not participate in this study justified by the member of the research team.
- •. Patient is under or plans to receive Chinese traditional medicine or herb drugs.
- •. Patient is under or plans to receive hospice care.
- •. Patient took other clinical trial testing drug within 3 months before enrollment.
- •. Patient can not quit drug abuse or heavy alcohol drinking.
研究组 & 干预措施
colchicine group
The participants will receive colchicine starting from 2 tablets after meal twice per day (total 2 mg). The dose will be adjusted ranging from total minimum 1.5 mg to maximum 3 mg per day based on the condition and tolerance of the participant. One cycle of treatment is defined as 4 days treatment and 3 days off. The participants will receive repeated cycles till the participants quit the trial.
干预措施: Colchicine Tablets (Drug)
结局指标
主要结局
survival
时间窗: through study completion, an average of 31 months
The overall survival of the participants
次要结局
- serious adverse effect(through study completion, an average of 31 months)
研究者
Zu-Yau Lin
professor
Kaohsiung Medical University Chung-Ho Memorial Hospital