A clinical study on safety and efficacy of System-i as new indwelling catheter system for hepatic arterial chemotherapy.
Phase 1
- Conditions
- hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000016887
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
1) ECOG performance status 3. 2) Uncontrollable extra-hepatic metastasis. 3) Symptomatic or under medication cardiac disease. 4) Having other cancer. 5) Having severe dysfunction (HCC rapture, uncontrolled diabetes, heart failure, MI, Arrhythmia, etc). 6) Having possibility of pregnant or nursing. 7) Deemed inappropriate to perform the study by the physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate of therapy (TACE or TAI) and safety
- Secondary Outcome Measures
Name Time Method Implantation time of system response rate complication (liver dysfunction, stenosis of catheter)