JPRN-UMIN000009149
Recruiting
Phase 1
Efficacy and safety of transcatheter arterial chemoembolization using combination of epirubicin and miriplatin for hepatocellular carcinoma -Prospective comparative study with transcatheter arterial chemoembolization using epirubicin- - TACE using combination of epirubicin&miriplatin for HCC - Prospective comparative study with TACE using epirubicin
ConditionsHepatocellular carcinoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatocellular carcinoma
- Sponsor
- Kansai Medical University
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) History of previous treatment by platinum drugs. 2\) Extrahepatic metastasis. 3\) Advanced vascular or biliary invasion (Vp3, Vp4, Vv3, B3, B4\). 4\) Severe arterio\-portal shunt or arterio\-venous shunt. 5\) Difficult to perform transcatheter arterial chemotherapy. 6\) History of the biliary tract reconstruction or treatment. 7\) Patients with following severe complicating disease(except chronic hepatitis and liver cirrhosis). 1\. Heart failure 2\. Renal failure(GFR:\<15mL/min/1\.73m2\) 3\. Active infections(except viral hepatitis) 4\. Active gastrointestinal bleeding 5\. Active duplicative cancer 6\. Hepatic encephalopathy or severe mental illness 8\) Fever\>\=38\.0 degrees Celsius. 9\) History of hypersensitivity to iodine\-containing contrast agent, gadolinium\-containing contrast agent, epirubicin and platinum\-containing drug. 10\) Patients who are pregnant, lactating, suspected to be pregnant, or wish to become pregnant. 11\) Patients who are concluded to be inappropriate to undergo TACE by angiography. 12\) Patients who are concluded to be inappropriate to participate in this study by their physicians.
Outcomes
Primary Outcomes
Not specified
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