Trial Outcomes & Findings for Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma (NCT NCT01935700)

NCT ID: NCT01935700

Last Updated: 2020-08-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

up to 72 months

Results posted on

2020-08-19

Participant Flow

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

one screening failure dut to active gastrointestinal hemorrhage

Participant milestones

Participant milestones
Measure	Colchicine Treated Patients 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: 1. 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. 1. Total daily dose reduced to 2.5 mg (1mg morning, 0.5 mg afternoon, 1 mg night) for participant with Child class B. 2. If the participant changed to Child class C, colchicine will be stopped and participant received regular follow-up only. 2. Colchicine was temporarily stopped in participant suffered from diarrhea and was started again with reducing daily total dose of 0.5 mg. 3. 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.	Sorafenib Treated Group 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.
Overall Study STARTED	14	86
Overall Study COMPLETED	9	86
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Colchicine Treated Patients 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: 1. 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. 1. Total daily dose reduced to 2.5 mg (1mg morning, 0.5 mg afternoon, 1 mg night) for participant with Child class B. 2. If the participant changed to Child class C, colchicine will be stopped and participant received regular follow-up only. 2. Colchicine was temporarily stopped in participant suffered from diarrhea and was started again with reducing daily total dose of 0.5 mg. 3. 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.	Sorafenib Treated Group 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.
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	4	0

Baseline Characteristics

Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colchicine Treated Patients n=9 Participants This group included participants receiving total daily colchicine dose equal or larger than 1.5 mg for more than 8 cycles (28 days).	Sorafenib Treated Group n=86 Participants 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 n=95 Participants Total of all reporting groups
Age, Continuous	60 years n=99 Participants	62 years n=107 Participants	62 years n=206 Participants
Sex: Female, Male sex · Female	1 Participants n=99 Participants	19 Participants n=107 Participants	20 Participants n=206 Participants
Sex: Female, Male sex · Male	8 Participants n=99 Participants	67 Participants n=107 Participants	75 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=99 Participants	86 Participants n=107 Participants	95 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	9 Participants n=99 Participants	86 Participants n=107 Participants	95 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Taiwan	9 Participants n=99 Participants	86 Participants n=107 Participants	95 Participants n=206 Participants

PRIMARY outcome

Timeframe: up to 72 months

Population: median survival

Outcome measures

Outcome measures
Measure	Colchicine Group n=9 Participants Participant received more than 8 courses of colchicine management.	Sorafenib Treated Group n=86 Participants 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.
Overall Survival	333 days Interval 123.0 to 1000.0	290 days Interval 74.0 to 1560.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Colchicine Group n=14 Participants Participant received more than 8 courses of colchicine management.	Sorafenib Treated Group n=86 Participants 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.
Grade III Severe Adverse Events Peritonitis	2 participants	1 participants
Grade III Severe Adverse Events Cholangitis	2 participants	2 participants
Grade III Severe Adverse Events Pleural effusion	0 participants	1 participants
Grade III Severe Adverse Events Diarrhea	1 participants	4 participants
Grade III Severe Adverse Events Anorexia	1 participants	0 participants
Grade III Severe Adverse Events Biliary tract obstruction	2 participants	0 participants
Grade III Severe Adverse Events Abdominal pain	1 participants	3 participants
Grade III Severe Adverse Events Hypoglycemia	1 participants	0 participants
Grade III Severe Adverse Events Pneumonia	3 participants	4 participants
Grade III Severe Adverse Events Sepsis	0 participants	2 participants
Grade III Severe Adverse Events Skin rash	0 participants	1 participants
Grade III Severe Adverse Events Palmar-plantar erythrodysesthesia syndrome	0 participants	4 participants
Grade III Severe Adverse Events Hypertension	0 participants	2 participants
Grade III Severe Adverse Events Hemorrhage	0 participants	8 participants
Grade III Severe Adverse Events Hyperglycemia	0 participants	1 participants
Grade III Severe Adverse Events Hypocalcemia	0 participants	1 participants

Adverse Events

Colchicine Group

Serious events: 10 serious events

Other events: 14 other events

Deaths: 13 deaths

Sorafenib Treated Group

Serious events: 33 serious events

Other events: 74 other events

Deaths: 81 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Colchicine Group n=14 participants at risk 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.	Sorafenib Treated Group n=86 participants at risk 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.
Gastrointestinal disorders diarrhea	100.0% 14/14 • Number of events 40 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	41.9% 36/86 • Number of events 83 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	36.0% 31/86 • Number of events 58 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Gastrointestinal disorders Nausea/vomiting	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	17.4% 15/86 • Number of events 28 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Skin and subcutaneous tissue disorders Hair loss	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	16.3% 14/86 • Number of events 18 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Vascular disorders Hypertension	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	15.1% 13/86 • Number of events 17 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Skin and subcutaneous tissue disorders Skin rash	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	15.1% 13/86 • Number of events 29 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Gastrointestinal disorders Oral mucositis	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	5.8% 5/86 • Number of events 6 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.

Additional Information

Dr. Zu-Yau Lin

Kaohsiung Medical University Hospital

Phone: 88677317123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Colchicine Group n=14 participants at risk 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.	Sorafenib Treated Group n=86 participants at risk 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.
Gastrointestinal disorders diarrhea	7.1% 1/14 • Number of events 1 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	4.7% 4/86 • Number of events 4 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Gastrointestinal disorders anorexia	7.1% 1/14 • Number of events 1 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	0.00% 0/86 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Hepatobiliary disorders biliary tract obstruction	14.3% 2/14 • Number of events 3 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	0.00% 0/86 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Gastrointestinal disorders abdominal pain	7.1% 1/14 • Number of events 1 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	3.5% 3/86 • Number of events 3 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Infections and infestations pneumonia	21.4% 3/14 • Number of events 3 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	4.7% 4/86 • Number of events 5 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Infections and infestations peritonotis	14.3% 2/14 • Number of events 2 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	1.2% 1/86 • Number of events 1 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Infections and infestations Cholangitis	14.3% 2/14 • Number of events 3 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	2.3% 2/86 • Number of events 2 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Infections and infestations Sepsis	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	2.3% 2/86 • Number of events 2 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Skin and subcutaneous tissue disorders Skin rash	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	1.2% 1/86 • Number of events 1 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	4.7% 4/86 • Number of events 5 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Vascular disorders Hypertension	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	2.3% 2/86 • Number of events 2 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Vascular disorders Hemorrhage	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	9.3% 8/86 • Number of events 11 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Endocrine disorders Hypoglycemia	7.1% 1/14 • Number of events 1 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	0.00% 0/86 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Endocrine disorders Hyperglycemia	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	1.2% 1/86 • Number of events 1 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	1.2% 1/86 • Number of events 1 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/14 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.	1.2% 1/86 • Number of events 1 • up to 72 months The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.