A Phase 2 interventional study of Colchicine in Hepatocellular Carcinoma, Metastasis and Invasion, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-08-19.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Phase 2, Interventional, and Treatment
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.
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:
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.
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.
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.
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.
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 15 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
2 tablets (0.5 mg/tablet) of colchicine three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial
Drug: Colchicine
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.
Also known as: Colicine, Tunfon and others, Drugbank Accession Number DB01394, PubChem CID 6167, CAS Registry Number: 64-86-8
Overall Survival
The overall survival of the participants calculated from the date of enrollment to the date of death will be compared with the control group with the same TNM and the Barcelona Clinic Liver Cancer (BCLC) staging collected from 2005/1/1 to the end of this study. The overall survival of the control group was calculated from the date of receiving sorafenib treatment to the date of death.
Time frame: up to 72 months
Grade III Severe Adverse Events
The type and frequency of grade III severe adverse events based on the Common Terminology Criteria for Adverse Events (CTCAE) noted during the study period.
Time frame: up to 72 months
from 2013-6-6 to 2019-5-31 in Kaohsiung Medical University Hospital total 15 participants were included for screening, one screening failure, 14 participants received colchicine management
| Milestone | Colchicine Treated Patients | Sorafenib Treated Group |
|---|---|---|
| Started | 14 | 86 |
| Completed | 9 | 86 |
| Not completed | 5 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Physician decision | 4 | 0 |
The overall survival of the participants calculated from the date of enrollment to the date of death will be compared with the control group with the same TNM and the Barcelona Clinic Liver Cancer (BCLC) staging collected from 2005/1/1 to the end of this study. The overall survival of the control group was calculated from the date of receiving sorafenib treatment to the date of death.
| days | Colchicine Group | Sorafenib Treated Group |
|---|---|---|
| Overall Survival | 333 (123 to 1000) | 290 (74 to 1560) |
The type and frequency of grade III severe adverse events based on the Common Terminology Criteria for Adverse Events (CTCAE) noted during the study period.
| participants | Colchicine Group | Sorafenib Treated Group |
|---|---|---|
| Diarrhea | 1 | 4 |
| Anorexia | 1 | 0 |
| Biliary tract obstruction | 2 | 0 |
| Abdominal pain | 1 | 3 |
| Hypoglycemia | 1 | 0 |
| Pneumonia | 3 | 4 |
| Peritonitis | 2 | 1 |
| Cholangitis | 2 | 2 |
| Sepsis | 0 | 2 |
| Skin rash | 0 | 1 |
| Palmar-plantar erythrodysesthesia syndrome | 0 | 4 |
| Hypertension | 0 | 2 |
| Hemorrhage | 0 | 8 |
| Hyperglycemia | 0 | 1 |
| Hypocalcemia | 0 | 1 |
| Pleural effusion | 0 | 1 |
Collected over up to 72 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Colchicine Group | 13/14 (92.9%) | 10/14 (71.4%) | 14/14 (100%) |
| Sorafenib Treated Group | 81/86 (94.2%) | 33/86 (38.4%) | 74/86 (86%) |
| Event | Colchicine Group | Sorafenib Treated Group |
|---|---|---|
| pneumoniaInfections and infestations | 3/14 | 4/86 |
| biliary tract obstructionHepatobiliary disorders | 2/14 | 0/86 |
| peritonotisInfections and infestations | 2/14 | 1/86 |
| CholangitisInfections and infestations | 2/14 | 2/86 |
| HemorrhageVascular disorders | 0/14 | 8/86 |
| diarrheaGastrointestinal disorders | 1/14 | 4/86 |
| anorexiaGastrointestinal disorders | 1/14 | 0/86 |
| abdominal painGastrointestinal disorders | 1/14 | 3/86 |
| HypoglycemiaEndocrine disorders | 1/14 | 0/86 |
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 0/14 | 4/86 |
| Event | Colchicine Group | Sorafenib Treated Group |
|---|---|---|
| diarrheaGastrointestinal disorders | 14/14 | 36/86 |
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 0/14 | 31/86 |
| Nausea/vomitingGastrointestinal disorders | 0/14 | 15/86 |
| Hair lossSkin and subcutaneous tissue disorders | 0/14 | 14/86 |
| HypertensionVascular disorders | 0/14 | 13/86 |
| Skin rashSkin and subcutaneous tissue disorders | 0/14 | 13/86 |
| Oral mucositisGastrointestinal disorders | 0/14 | 5/86 |
The participant received more than 8 courses of colchicine management.
| Age, Continuous(years) | Colchicine Treated Patients | Sorafenib Treated Group | Total |
|---|---|---|---|
| Median | 60 (53 to 77) | 62 (26 to 83) | 62 (26 to 83) |
| Sex: Female, Male(Participants) | Colchicine Treated Patients | Sorafenib Treated Group | Total |
|---|---|---|---|
| sex — Female | 1 | 19 | 20 |
| sex — Male | 8 | 67 | 75 |
| Ethnicity (NIH/OMB)(Participants) | Colchicine Treated Patients | Sorafenib Treated Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 9 | 86 | 95 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Colchicine Treated Patients | Sorafenib Treated Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 9 | 86 | 95 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Colchicine Treated Patients | Sorafenib Treated Group | Total |
|---|---|---|---|
| Taiwan | 9 | 86 | 95 |
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Kaohsiung Medical University Chung-Ho Memorial Hospital