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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01935700 |
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Date of registration:
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24/08/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma
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Scientific title:
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Evaluation the Potential of Colchicine for the Palliative Management of Hepatocellular Carcinoma Patients With Distant Metastasis or Large Vessel Invasion |
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Date of first enrolment:
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June 6, 2013 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01935700 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Zu Y Lin, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kaohsiung Medical University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatocellular Carcinoma
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Invasion
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Metastasis
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Intervention(s)
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Drug: Colchicine
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Primary Outcome(s)
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Overall Survival
[Time Frame: up to 72 months]
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Secondary Outcome(s)
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Grade III Severe Adverse Events
[Time Frame: up to 72 months]
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Secondary ID(s)
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2013-04-03(I)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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