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Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264260
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
Kaohsiung Medical University
Information provided by (Responsible Party):
Zu-Yau Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary:
This trial is to evaluate the palliative effects of colchicine on primary hepatic malignancy using the Department of Health R.O.C. approved doses and methods of administration. Colchicine will be started from 2 tablets after meal twice per day (total 2 mg), adjust the dose ranging from total minimum 1.5 mg to maximum 3 mg per day based on the condition and tolerance of the participant. One cycle of treatment is defined as 4 days treatment and 3 days off. The participants will receive repeated treatment cycles till the participants quit the trial. The control group will be originated from review of (1) patients treated by members of this research team with the same condition as the trial selected participants but not included in the trial, (2) patients with same condition as the trial selected participants reported in the literatures. The primary objective is to evaluate the palliative effects of colchicine on primary hepatic malignancy unable to receive curative treatment. The primary end point is survival of the participant. The Secondary objective is to evaluate the safety of patients treated by colchicine and the secondary end point is the side effects of colchicine.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Stage IIIB Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma; With Hepatocellular Carcinoma Hepatocellular Carcinoma Stage IV Drug: Colchicine Tablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open labeled
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment
Actual Study Start Date : December 24, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: colchicine group
The participants will receive colchicine starting from 2 tablets after meal twice per day (total 2 mg). The dose will be adjusted ranging from total minimum 1.5 mg to maximum 3 mg per day based on the condition and tolerance of the participant. One cycle of treatment is defined as 4 days treatment and 3 days off. The participants will receive repeated cycles till the participants quit the trial.
Drug: Colchicine Tablets
three times or two times per day after meal with the daily total dose ranging from 1.5 to 3 mg




Primary Outcome Measures :
  1. survival [ Time Frame: through study completion, an average of 31 months ]
    The overall survival of the participants


Secondary Outcome Measures :
  1. serious adverse effect [ Time Frame: through study completion, an average of 31 months ]
    The events of serious adverse effect occurred during the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(A). Primary hepatic malignancy including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, hepatocellular-cholangiocarcinoma, poorly differentiated or undifferentiated primary hepatic malignancy.

  1. Diagnosis of hepatocellular carcinoma: 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 on contrast-enhanced computed tomography or magnetic resonance imaging.
  2. Diagnosis of intrahepatic cholangiocarcinoma: Patient has at least one of the following criteria: (1) evidenced by cytology or pathology, (2) serum CA19-9 level > 10 times of normal upper limit and has evidence on contrast-enhanced computed tomography or magnetic resonance imaging, and no evidence of extrahepatic original malignancy.
  3. Diagnosis of hepatocellular-cholangiocarcinoma: concomitantly fit at least one of the items described in (a) and (b)
  4. Diagnosis of poorly differentiated or undifferentiated primary hepatic malignancy: Patient fits all of the following criteria: (1) evidenced of malignancy other than hepatocellular carcinoma, intrahepatic cholangiocarcinoma or hepatocellular-cholangiocarcinoma by cytology or pathology, (2) no evidence of extrahepatic original malignancy

(B). Primary hepatic malignant tumors unable to receive curative treatment indicate that the malignancy can not be completely eliminated by operative resection, liver transplantation or local abrasion therapy. Patient also needs to fit at least one of the following criteria: (1) evidence of distant metastasis or large vessels (intrahepatic first branch portal vein, portal main trunk, major hepatic vein or inferior vena cava) invasion, (2) unable to be controlled by transcatheter arterial chemoembolization including appearance of new rather than incompletely treated nodules within 3 months of chemoembolization, or chemoembolization fails

(C). The performance status of the patient based on the Eastern Cooperative Oncology Group (ECOG) belongs to 0 or 1 and the calculated Child score is below 8 points.

Exclusion Criteria:

  1. . life-threatening hemorrhage at the present time
  2. . life-threatening bacterial, fungal or viral infection (not included hepatitis B and C virus) at the present time
  3. . extrahepatic original malignancy unable to be controlled
  4. . serum creatinine level > 1.5 mg/dL.
  5. . Patient must receive long-term statin or fibrates drugs. The doses of these medications can not be altered.
  6. . Patient has white blood cell count < 1500/µL, platelet count < 30000/µL or hemoglobin < 9.0 gm/dL after medication.
  7. . Pregnant woman or plan to be a pregnant woman
  8. . allergy to colchicine or has history of severe side effects caused by colchicine
  9. . Patient has received systemic chemotherapy within 2 months before enrollment or plans to receive systemic chemotherapy in the future.
  10. . Patient is under or plans to receive other clinical trial testing drug.
  11. . Patient has severe malfunction of vital organs and can not participate in this study justified by the member of the research team.
  12. . Patient is under or plans to receive Chinese traditional medicine or herb drugs.
  13. . Patient is under or plans to receive hospice care.
  14. . Patient took other clinical trial testing drug within 3 months before enrollment.
  15. . Patient can not quit drug abuse or heavy alcohol drinking.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264260


Contacts
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Contact: Zu Y Lin, MD 88673121101 ext 7475 linzuyau@yahoo.com.tw

Locations
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Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Zu Y Lin, MD    88673121101 ext 7475    linzuyau@yahoo.com.tw   
Principal Investigator: Zu Y Lin, MD         
Sub-Investigator: Wan L Chuang, PhD         
Sub-Investigator: Ming L Yu, PhD         
Sub-Investigator: Chia Y Dai, PhD         
Sub-Investigator: Shinn C Chen, PhD         
Sub-Investigator: Jee F Huang, PhD         
Sub-Investigator: Chung F Huang, PhD         
Sub-Investigator: Ching I Huang, MD         
Sub-Investigator: Po C Liang, MD         
Sub-Investigator: Cheng T Hsu, MD         
Sub-Investigator: Po Y Hsu, MD         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University
Investigators
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Principal Investigator: Zu Y Lin, MD Kaohsiung Medical University
Publications:

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Responsible Party: Zu-Yau Lin, professor, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT04264260    
Other Study ID Numbers: KMUHIRB-F(II)-20190152
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zu-Yau Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital:
hepatocellular carcinoma
Cholangiocarcinoma
primary hepatic malignancy
palliative treatment
colchicine
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Cholangiocarcinoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents