Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment

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.

Timeline

Start

2019-12-24

Primary completion

2025-05-30

Completion

2025-05-30

Publications

• Background Arrieta O, Rodriguez-Diaz JL, Rosas-Camargo V, Morales-Espinosa D, Ponce de Leon S, Kershenobich D, Leon-Rodriguez E. Colchicine delays the development of hepatocellular carcinoma in patients with hepatitis virus-related liver cirrhosis. Cancer. 2006 Oct 15;107(8):1852-8. doi: 10.1002/cncr.22198.
• Background Finkelstein Y, Aks SE, Hutson JR, Juurlink DN, Nguyen P, Dubnov-Raz G, Pollak U, Koren G, Bentur Y. Colchicine poisoning: the dark side of an ancient drug. Clin Toxicol (Phila). 2010 Jun;48(5):407-14. doi: 10.3109/15563650.2010.495348.
• Background Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6. doi: 10.1161/CIRCULATIONAHA.105.542738.
• Background Kallinich T, Haffner D, Niehues T, Huss K, Lainka E, Neudorf U, Schaefer C, Stojanov S, Timmann C, Keitzer R, Ozdogan H, Ozen S. Colchicine use in children and adolescents with familial Mediterranean fever: literature review and consensus statement. Pediatrics. 2007 Feb;119(2):e474-83. doi: 10.1542/peds.2006-1434. Epub 2007 Jan 22.
• Background Leighton JA, Bay MK, Maldonado AL, Schenker S, Speeg KV. Colchicine clearance is impaired in alcoholic cirrhosis. Hepatology. 1991 Dec;14(6):1013-5.
• Background Rochdi M, Sabouraud A, Girre C, Venet R, Scherrmann JM. Pharmacokinetics and absolute bioavailability of colchicine after i.v. and oral administration in healthy human volunteers and elderly subjects. Eur J Clin Pharmacol. 1994;46(4):351-4. doi: 10.1007/BF00194404.
• Background Ferron GM, Rochdi M, Jusko WJ, Scherrmann JM. Oral absorption characteristics and pharmacokinetics of colchicine in healthy volunteers after single and multiple doses. J Clin Pharmacol. 1996 Oct;36(10):874-83. doi: 10.1002/j.1552-4604.1996.tb04753.x.
• Background Terkeltaub RA, Furst DE, Bennett K, Kook KA, Crockett RS, Davis MW. High versus low dosing of oral colchicine for early acute gout flare: Twenty-four-hour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study. Arthritis Rheum. 2010 Apr;62(4):1060-8. doi: 10.1002/art.27327.
• Background Lin ZY, Wu CC, Chuang YH, Chuang WL. Anti-cancer mechanisms of clinically acceptable colchicine concentrations on hepatocellular carcinoma. Life Sci. 2013 Sep 3;93(8):323-8. doi: 10.1016/j.lfs.2013.07.002. Epub 2013 Jul 16.
• Background Wu CC, Lin ZY, Kuoc CH, Chuang WL. Clinically acceptable colchicine concentrations have potential for the palliative treatment of human cholangiocarcinoma. Kaohsiung J Med Sci. 2015 May;31(5):229-34. doi: 10.1016/j.kjms.2015.01.008. Epub 2015 Mar 10.
• Background Lin ZY, Kuo CH, Wu DC, Chuang WL. Anticancer effects of clinically acceptable colchicine concentrations on human gastric cancer cell lines. Kaohsiung J Med Sci. 2016 Feb;32(2):68-73. doi: 10.1016/j.kjms.2015.12.006. Epub 2016 Feb 2.
• Lin ZY, Yeh ML, Liang PC, Chen SC, Huang CF, Huang JF, Dai CY, Yu ML, Chuang WL. Phase IIb Trial for the Palliative Treatment of Patients With Primary Hepatic Malignancy Unable to Receive Curative Treatment: Efficacy of Colchicine. Kaohsiung J Med Sci. 2026 May;42(5):e70121. doi: 10.1002/kjm2.70121. Epub 2025 Sep 27.

Drugs

Indications