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Hepatocellular CarcinomaPhase 2NCT01935700

Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma

A Phase 2 study testing Colchicine in people with Hepatocellular Carcinoma and Metastasis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Hepatocellular Carcinoma, Metastasis, Invasion
What is being tested?
Colchicine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteTaiwan
Study dates
6 Jun 2013to 31 May 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • . 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.
  • . Contrast-enhanced computed tomography or magnetic resonance imaging has evidence of distant metastasis or large vessel invasion caused by hepatocellular carcinoma.
  • . Patient has Child A hepatic reserved function

Who cannot join

  • . There are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.
  • . There are life-threatening bacterial, fungal or viral infection (not included hepatitis B and C virus).
  • . Patient has serum creatinine level > 1.5 mg/dL.
  • . Patient must receive long-term medication of statin or fibrates drugs and these medications can not be changed.
  • . Patient has white blood cell count < 1500/µL, platelet count < 30000/µL or hemoglobin < 9.0 gm/dL after medication.
  • . Pregnant woman or plan to be a pregnant woman
Show all 11Show fewer
  • . allergy to colchicine or has history of severe side effects caused by colchicine
  • . Patient has received systemic chemotherapy within 2 months before enrollment or plans to receive systemic chemotherapy in the future.
  • . Patient is under or plans to receive Nexavar or other clinical trial testing drug.
  • . Patient has severe malfunction of vital organs and can not participate in this study justified by the doctor in this research team.
  • . Patient is under or plans to receive Chinese traditional medicine or herb drugs.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

Other trials in Taiwan

About this study

Official title: Evaluation the Potential of Colchicine for the Palliative Management of Hepatocellular Carcinoma Patients With Distant Metastasis or Large Vessel Invasion

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.

Read the 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.
  7. 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.
  8. 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.
  9. There are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.
  10. . There are life-threatening bacterial, fungal or viral infection (not included hepatitis B and C virus).
  11. . Patient has serum creatinine level > 1.5 mg/dL.
  12. . Patient has white blood cell count < 1500/µL, platelet count < 30000/µL or hemoglobin < 9.0 gm/dL after medication.
  13. 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.
  14. 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.

Being tested
Colchicine
Keywords
hepatocellular carcinoma, colchicine
Medical subject headings
Carcinoma, Hepatocellular, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

    Also called Colicine, Tunfon and others, Drugbank Accession Number DB01394, PubChem CID 6167, CAS Registry Number: 64-86-8

    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.

Study groups in NCT01935700
Study groupRoleWhat they receive
colchicine treated patientsExperimental2 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
Receives: Drug: Colchicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 72 months

Secondary outcomes (1)

  1. 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.

    Measured: up to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2013 (estimated)
  2. Study start6 Jun 2013
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
opeo labeled
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01935700
Sponsor's protocol ID
2013-04-03(I)
Status last verified
Aug 2020
First submitted
24 Aug 2013
Last updated
19 Aug 2020
Data monitoring committee
No

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.

    PubMed 23871804

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Colchicine in people with Hepatocellular Carcinoma and Metastasis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: up to 72 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01935700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.

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