Transcatheter arterial infusion chemotherapy using cisplatin powder and iodized-oil for advanced hepatocellular carcinoma: a phase 2 study
- Conditions
- HCC
- Registration Number
- JPRN-UMIN000005495
- Lead Sponsor
- Japan Society of Transcatheter Hepatic Arterial Embolization Clinical Reserch Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
1)History of previous treatment by platinum drugs. 2)Extrahepatic metastasis. 3)Advanced vascular or biliary invasion (Vp4,Vv3,B3,B4). 4)Sever 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 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, 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 participate in this study by their physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate (RR)
- Secondary Outcome Measures
Name Time Method Safty Tumor markers Overall survival (OS) 6-months survival rate 1-year survival rate Progression free survival (PFS)