Evaluating colchicine for palliative care in advanced liver cancer

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

This study is testing if colchicine can help improve the quality of life and relieve symptoms for patients with advanced liver cancer who can't receive other treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 20 Years to 85 Years
• Sex: All
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Kaohsiung)
• Trial ID: NCT04264260 on ClinicalTrials.gov

What this trial studies

This trial evaluates the palliative effects of colchicine on patients with primary hepatic malignancies, such as hepatocellular carcinoma and cholangiocarcinoma, who are unable to receive curative treatment. Participants will take colchicine in a controlled dosage regimen, starting with 2 mg per day and adjusting based on tolerance and liver function. The study aims to assess the drug's effectiveness in alleviating symptoms and improving quality of life. A control group will be established from historical data of similar patients not enrolled in the trial.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with advanced hepatocellular carcinoma or cholangiocarcinoma who cannot undergo curative treatment.

Not a fit: Patients with early-stage liver cancer or those who are candidates for curative treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant symptom relief and improved quality of life for patients with advanced liver cancer.

How similar studies have performed: While colchicine has been studied for various conditions, its use in this specific context for advanced liver cancer is novel and has not been extensively tested.

Eligibility 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.

Where this trial is running

Kaohsiung

• Kaohsiung Medical University Hospital — Kaohsiung, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Zu Y Lin, MD — Kaohsiung Medical University
• Study coordinator: Zu Y Lin, MD

Conditions: Hepatocellular Carcinoma Stage IIIB, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, With Hepatocellular Carcinoma, Hepatocellular Carcinoma Stage IV, hepatocellular carcinoma, primary hepatic malignancy, palliative treatment