Phase II study of artificial tumor-antigens (GPC3/AFP/MAGE1) pulsed dendritic cell vaccination for patients with hepatocellular carcinoma after curative resectio
Phase 2
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000021545
- Lead Sponsor
- Kitasato Institute Hospital, Kitasato University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1) Sever hemorrhagic diathesis 2) Sever psychiatric or mental disorder 3) Severe comorbidity of heart disease (NYHA classIII, IV) 4) Past history of autoimmune disease (PSS, Sjogren syndrome, ITP, MS, RA etc.) 5) During treatment with immunosuppressive agents 6)Suspicious of immunodeficiency or opportunistic infection 7)Severe allergy with penicillin or picibanil 8) Pantients with adverse events of CTCAE v4.0 >= grade 3 of nonhematological toxicity, or >= grade 4 of hematological toxicity 9) Pregnancy, nursing women 10) Male hope to impregnate 11) Patients whom doctors judged inadequate to the enrollment of this study by other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-year recurrence rate
- Secondary Outcome Measures
Name Time Method Recurrence free survival rate Grade and efficient of SAE and adverse events Induction antigen-specific immune response