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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

Phase 1
Recruiting
Conditions
Hepatocellular carcinoma
Registration Number
JPRN-UMIN000009149
Lead Sponsor
Kansai Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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