Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Metastasis; Invasion
MeSH terms: Carcinoma; Neoplasm Metastasis; Carcinoma, Hepatocellular
Intervention: Colchicine
Intervention description: 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.
Intervention MeSH terms: Colchicine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: opeo labeled
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 20 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: hepatocellular carcinoma; colchicine

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. . 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 provided by contrast-enhanced
             computed tomography or magnetic resonance imaging.

          2. . Contrast-enhanced computed tomography or magnetic resonance imaging has evidence of
             distant metastasis or large vessel invasion caused by hepatocellular carcinoma.

          3. . Patient has Child A hepatic reserved function

        Exclusion Criteria:

          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 must receive long-term medication of statin or fibrates drugs and these
             medications can not be changed.

          5. . Patient has white blood cell count < 1500/µL, platelet count < 30000/µL or
             hemoglobin < 9.0 gm/dL after medication.

          6. . Pregnant woman or plan to be a pregnant woman

          7. . allergy to colchicine or has history of severe side effects caused by colchicine

          8. . Patient has received systemic chemotherapy within 2 months before enrollment or
             plans to receive systemic chemotherapy in the future.

          9. . Patient is under or plans to receive Nexavar or other clinical trial testing drug.

         10. . Patient has severe malfunction of vital organs and can not participate in this study
             justified by the doctor in this research team.

         11. . Patient is under or plans to receive Chinese traditional medicine or herb drugs.