A Phase II study of CreaVax-HCC in patients with resectable and/or non-resectable hepatocellular carcinoma
- Conditions
- Neoplasms
- Registration Number
- KCT0000008
- Lead Sponsor
- JW CreaGene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 156
(1) Among Patients with modified UICC Stage I, II and III by radiation examination (CT or MRI), a patient with CR (Complete response) state by resectable and/or non- resectable (TACE, PEIT, RFA) treatment (in less than 2 times) within 4 month registration
(2) A patient aged over 20 / both male and female
(3) A patient with ECOG scale (ECOG-PS) 0-1
(4) A patient over 3 months survival expected
(5) Hemoglobin = 8.5g/dL, WBC = 2,000/mm3, Platelet = 50,000/ mm3
(6) Child Pugh score =7, ALT(Alanine transaminase), AST(aspartate aminotransferase) = 5 x ULN
(7) Creatinine < 1.5mg/dL
(8) A patient who signed the written consent form by onself
(1) A patient with organ- transplantation
(2) A patient with other cancer or the history of cancer within the last 5 years
(3) A patient with the medical history of autoimmune disease or with immunodeficiency or autoimmune disease that might be aggravated by immunotherapy
(4) A patient not exceeding two weeks after antibiotic treatment needed due to a serious infectious disease.
(5) A HIV positive patient
(6) A patient with cardiopulmonary disability judged by the investigator
(7) A patient with the medical history of psychological disease or epilepsy
(8) A patient who has participated in another clinical trial within the last 4 weeks of the start of study
(9) A pregnant woman, breast-feeding woman or woman who wants to be pregnant during the trial period
(10)A patient with 4 month later after first-line therapy and a recurrent hepatocelluar carcinoma patient
(1) A patient with systemic therapy to treat hepatocellular carcinoma
(2) A patient administered immunosuppressive drug like cyclosporin A,
Azathioprine
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence free survival rate
- Secondary Outcome Measures
Name Time Method Recurrence rate;Time to Recurrence;Overall Survival;Cancer antigen specific celluous immune response induction;Concetration change of AFP & PIVKAII in blood