Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment
Status:
Recruiting
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital