Old gout drug tested as new hope for advanced liver cancer
NCT ID NCT04264260
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2 trial tested colchicine, a drug usually used for gout, in 42 people with advanced liver cancer that could not be treated with curative intent. Participants took colchicine tablets daily in cycles of 4 days on, 3 days off. The study measured how long patients survived and tracked side effects. Results were compared to similar patients from past records, not a placebo group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Colchicine tablets
- What this could lead to
- If it works, this could offer a new palliative option to help people with advanced liver cancer live longer and manage symptoms.
- What could go wrong
- This is a small, early-phase trial with only 42 participants and no randomized control group. Colchicine may cause side effects and might not improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
42 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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May 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 85 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
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