Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Metastasis; Invasion
MeSH terms: Carcinoma; Neoplasm Metastasis; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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:

        1. 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.

             1. 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

             2. If the hepatic reserved function of the participant returns to Child A, The dosage
                for Child A will be restored.

             3. If the hepatic reserved function of the participant changes to Child C, colchicine
                will be stopped and participant receives regular follow-up only.

        2. 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.

             1. 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﹞.

                If diarrhea attacks again, the dosage of colchicine will be changes to﹝2 tablets
                after breakfast and 2 tablets after dinner﹞.

                If diarrhea attacks again, the dosage of colchicine will be changes to﹝2 tablets
                after breakfast, 1 tablet after dinner﹞.

                If diarrhea also attacks again, colchicine will be stopped and participant receives
                regular follow-up only.

             2. For participant receives﹝2 tablets after breakfast, 1 tablet after lunch and 2
                tablets after dinner﹞, the dosage of colchicine will be changes to﹝2 tablets after
                breakfast and 2 tablets after dinner﹞.

           If diarrhea attacks again, the dosage of colchicine will be changes to﹝2 tablets after
           breakfast, 1 tablet after dinner﹞.

           If diarrhea also attacks again, colchicine will be stopped and participant receives
           regular follow-up only.

        3. If the participant has one of the following conditions, colchicine will be temporarily
           stopped. When the condition of the participant improves, colchicine will be given again
           after the judgment from the doctor of the research team. For participants unable to
           receive colchicine again, they will receive regular follow-up only.

             1. There are life-threatening hemorrhage including gastrointestinal hemorrhage and
                hemorrhage from other vital organs such as lungs or brain.

             2. . There are life-threatening bacterial, fungal or viral infection (not included
                hepatitis B and C virus).

             3. . Patient has serum creatinine level > 1.5 mg/dL.

             4. . Patient has white blood cell count < 1500/µL, platelet count < 30000/µL or
                hemoglobin < 9.0 gm/dL after medication.

             5. The research team decides that the participant is not suitable to continue the
                study caused by abnormality of any vital organ or severe side effects caused by the
                study.

        4. Colchicine will be temporarily stopped one day before transcatheter arterial
           chemoembolization until participant has body temperature < 38 ℃, same hepatic reserved
           function as before, and serum creatinine level < 1.5 mg/d after embolization.

      Follow-up procedures and items for the participants to co-operate:

      All participants will be followed according to the guide line of the National Health Council
      and the clinical practice in the treatment of hepatocellular carcinoma. Contrasted-enhanced
      computed tomography or magnetic resonance imaging will be performed within every 3 to 4
      months. Serum alpha-fetoprotein will be determined at least one session within every 2 to 3
      months in patients with elevated serum alpha-fetoprotein levels. The hepatic and renal
      function will be determined at least one session every month. The participants are asked to
      visit our outpatient clinic at least one session every month.
    

Intervention name(s): Colchicine
Intervention type(s): Drug
Intervention description(s): Adjustment the dosage of colchicine during study:
The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according as following: 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. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again but the dose will be reduced 0.5 mg/day.
Other intervention name(s): Colicine, Tunfon and others, Drugbank Accession Number DB01394, PubChem CID 6167, CAS Registry Number: 64-86-8
Intervention MeSH terms: Colchicine
Intervention model: Single Group Assignment
Intervention model description: opeo labeled
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; colchicine