A Phase II study of CreaVax-HCC in patients with resectable and/or non-resectable hepatocellular carcinoma

A Opened, Randomized, Multi-centered Phase II study on the efficacy and safety of CreaVax-HCC(Autologous Mature Dendritic Cells)in patients with hepatocellular carcinoma for comparing after a operation and/or non-operation therapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000008

Enrollment

156

Registered

2010-06-28

Start date

2010-06-15

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine : Dosage: 30 million cells/ injection Duration: 4 times every two weeks/ 2 times every four weeks/ total 6 times injections

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

Measure	Time frame
Recurrence free survival rate	—

Secondary

Measure	Time frame
Recurrence rate;Time to Recurrence;Overall Survival;Cancer antigen specific celluous immune response induction;Concetration change of AFP & PIVKAII in blood	—

Countries

Korea, Republic of

Contacts

Public ContactMin-kyu Heo

JW CreaGene

Outcome results