Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Rec… (NCT04264260) | Clinical Trial Compass
CompletedPhase 2
Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment
Taiwan42 participantsStarted 2019-12-24
Plain-language summary
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.
Who can participate
Age range20 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. . life-threatening hemorrhage at the present time
✕
What they're measuring
1
survival
Timeframe: through study completion, an average of 31 months
Trial details
NCT IDNCT04264260
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital