Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01935700
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 71.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma; Metastasis; Invasion	Drug: Colchicine	Phase 2

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.

2. 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

3. If the hepatic reserved function of the participant returns to Child A, The dosage for Child A will be restored.

4. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.

5. 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.

6. 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.

1. 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.

1. 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.

2. There are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.

3. . There are life-threatening bacterial, fungal or viral infection (not included hepatitis B and C virus).

4. . Patient has serum creatinine level > 1.5 mg/dL.

5. . Patient has white blood cell count < 1500/µL, platelet count < 30000/µL or hemoglobin < 9.0 gm/dL after medication.

6. 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.

7. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: opeo labeledopeo labeled
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation the Potential of Colchicine for the Palliative Management of Hepatocellular Carcinoma Patients With Distant Metastasis or Large Vessel Invasion
• Actual Study Start Date: Jun 6, 2013
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: colchicine treated patients 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.; Other Names: Colicine, Tunfon and others, Drugbank Accession Number DB01394, PubChem CID 6167, CAS Registry Number: 64-86-8

Outcome Measures

Primary Outcome Measures

1. Overall Survival [up to 72 months]

   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.

Secondary Outcome Measures

1. Grade III Severe Adverse Events [up to 72 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Medical University Hospital	Kaohsiung		Taiwan	807

Sponsors and Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

• Principal Investigator: Zu Y Lin, MS, Kaohsiung Medical University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 6, 2013

More Information

Publications

• 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.

• Responsible Party: Zu-Yau Lin, professor, Kaohsiung Medical University Chung-Ho Memorial Hospital
• ClinicalTrials.gov Identifier: NCT01935700
• Other Study ID Numbers: 2013-04-03(I)
• First Posted: Sep 5, 2013
• Last Update Posted: Aug 19, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Zu-Yau Lin, professor, Kaohsiung Medical University Chung-Ho Memorial Hospital: hepatocellular carcinoma; colchicine
• Additional relevant MeSH terms: Carcinoma; Neoplasm Metastasis; Carcinoma, Hepatocellular; Colchicine

Study Results

Participant Flow

Recruitment Details	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
Pre-assignment Detail	one screening failure dut to active gastrointestinal hemorrhage

Arm/Group Title	Colchicine Treated Patients	Sorafenib Treated Group
Arm/Group Description	The dosing schedule started from 1 mg three times per day after meal for 4 days and stopped for the following 3 days (1 cycle). This cycle was repeated till the participant quitted this trial. Adjustment of colchicine dosage during study: The colchicine dosage was changed when the hepatic reserved function of the participant changed from Child A to B or C according to the following rules. Total daily dose reduced to 2.5 mg (1mg morning, 0.5 mg afternoon, 1 mg night) for participant with Child class B. If the participant changed to Child class C, colchicine will be stopped and participant received regular follow-up only. Colchicine was temporarily stopped in participant suffered from diarrhea and was started again with reducing daily total dose of 0.5 mg. Colchicine was temporarily stopped when the participant fitted any of the exclusion criteria during the study, and was given again after the fitted exclusion criterion was eliminated.	This group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.
Period Title: Overall Study
STARTED	14	86
COMPLETED	9	86
NOT COMPLETED	5	0

Baseline Characteristics

Arm/Group Title	Colchicine Treated Patients	Sorafenib Treated Group	Total
Arm/Group Description	This group included participants receiving total daily colchicine dose equal or larger than 1.5 mg for more than 8 cycles (28 days).	This group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.	Total of all reporting groups
Overall Participants	9	86	95
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60	62	62
Sex: Female, Male (Count of Participants)
Female	1 11.1%	19 22.1%	20 21.1%
Male	8 88.9%	67 77.9%	75 78.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	9 100%	86 100%	95 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	9 100%	86 100%	95 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Taiwan	9 100%	86 100%	95 100%

Outcome Measures

1. Primary Outcome

Title	Overall Survival
Description	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

Outcome Measure Data

Analysis Population Description

median survival

Arm/Group Title	Colchicine Group	Sorafenib Treated Group
Arm/Group Description	Participant received more than 8 courses of colchicine management.	The control group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.
Measure Participants	9	86
Median (Full Range) [days]	333	290

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was defined as no statistically significant difference (P value > 0.05) in median survival between the colchicine group and the sorafenib treated group.
Statistical Test of Hypothesis	p-Value	0.4593
	Comments
	Method	Mann-Whitney U test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was defined as no statistically significant difference (P value > 0.05) in survival between the colchicine group and the sorafenib treated group.
Statistical Test of Hypothesis	p-Value	0.3290
	Comments
	Method	Log Rank
	Comments

2. Secondary Outcome

Title	Grade III Severe Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Group	Sorafenib Treated Group
Arm/Group Description	This included the events occured after the participant signed the inform consent.	This group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.
Measure Participants	14	86
Diarrhea	1 11.1%	4 4.7%
Anorexia	1 11.1%	0 0%
Biliary tract obstruction	2 22.2%	0 0%
Abdominal pain	1 11.1%	3 3.5%
Hypoglycemia	1 11.1%	0 0%
Pneumonia	3 33.3%	4 4.7%
Peritonitis	2 22.2%	1 1.2%
Cholangitis	2 22.2%	2 2.3%
Sepsis	0 0%	2 2.3%
Skin rash	0 0%	1 1.2%
Palmar-plantar erythrodysesthesia syndrome	0 0%	4 4.7%
Hypertension	0 0%	2 2.3%
Hemorrhage	0 0%	8 9.3%
Hyperglycemia	0 0%	1 1.2%
Hypocalcemia	0 0%	1 1.2%
Pleural effusion	0 0%	1 1.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of pneumonia between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	0.0552
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of biliary tract obstruction between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	0.0184
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of cholangitis between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	0.0931
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of peritonitis between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	0.0506
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of sepsis between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	1
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of diarrhea between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	0.5374
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of anorexia between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	0.14
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of abdominal pain between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	0.4584
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of skin rash between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	1
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of palmar-plantar erythrodysesthesia syndrome between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	1
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of hypertension between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	1
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of hemorrhage between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	0.5958
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of hypoglycemia between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	0.14
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of hyperglycemia between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	1
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of hypocalcemia between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	1
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Colchicine Group, Sorafenib Treated Group
	Comments	Comparison the incidence of grade III adverse event of pleural effusion between two groups
	Type of Statistical Test	Equivalence
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
Statistical Test of Hypothesis	p-Value	1
	Comments	The threshold for statistically significant difference in incidence was P = 0.05.
	Method	Fisher Exact
	Comments

Adverse Events

Time Frame	up to 72 months
Adverse Event Reporting Description	The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Arm/Group Title	Colchicine Group		Sorafenib Treated Group
Arm/Group Description	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 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.		The control group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.
All Cause Mortality
	Colchicine Group		Sorafenib Treated Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/14 (92.9%)		81/86 (94.2%)
Serious Adverse Events
	Colchicine Group		Sorafenib Treated Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/14 (71.4%)		33/86 (38.4%)
Endocrine disorders
Hypoglycemia	1/14 (7.1%)	1	0/86 (0%)	0
Hyperglycemia	0/14 (0%)	0	1/86 (1.2%)	1
Gastrointestinal disorders
diarrhea	1/14 (7.1%)	1	4/86 (4.7%)	4
anorexia	1/14 (7.1%)	1	0/86 (0%)	0
abdominal pain	1/14 (7.1%)	1	3/86 (3.5%)	3
Hepatobiliary disorders
biliary tract obstruction	2/14 (14.3%)	3	0/86 (0%)	0
Infections and infestations
pneumonia	3/14 (21.4%)	3	4/86 (4.7%)	5
peritonotis	2/14 (14.3%)	2	1/86 (1.2%)	1
Cholangitis	2/14 (14.3%)	3	2/86 (2.3%)	2
Sepsis	0/14 (0%)	0	2/86 (2.3%)	2
Metabolism and nutrition disorders
Hypocalcemia	0/14 (0%)	0	1/86 (1.2%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/14 (0%)	0	1/86 (1.2%)	1
Skin and subcutaneous tissue disorders
Skin rash	0/14 (0%)	0	1/86 (1.2%)	1
Palmar-plantar erythrodysesthesia syndrome	0/14 (0%)	0	4/86 (4.7%)	5
Vascular disorders
Hypertension	0/14 (0%)	0	2/86 (2.3%)	2
Hemorrhage	0/14 (0%)	0	8/86 (9.3%)	11
Other (Not Including Serious) Adverse Events
	Colchicine Group		Sorafenib Treated Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/14 (100%)		74/86 (86%)
Gastrointestinal disorders
diarrhea	14/14 (100%)	40	36/86 (41.9%)	83
Nausea/vomiting	0/14 (0%)	0	15/86 (17.4%)	28
Oral mucositis	0/14 (0%)	0	5/86 (5.8%)	6
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome	0/14 (0%)	0	31/86 (36%)	58
Hair loss	0/14 (0%)	0	14/86 (16.3%)	18
Skin rash	0/14 (0%)	0	13/86 (15.1%)	29
Vascular disorders
Hypertension	0/14 (0%)	0	13/86 (15.1%)	17

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.