Hepatocellular Carcinoma Clinical Trial
Official title:
Phase 2 Study of DC-CIK Cells Combined With TACE in the Treatment of Hepatocellular Carcinoma
Evaluation of DC-CIK cells combined TACE treatment for HCC
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 18-80 years old; - Histologically confirmed with Hepatocellular Carcinoma at stage I-II; - Patients who can accept Transcatheter Arterial Chemoembolization ; - Patients who have a life expectancy of at least 3 months; - Patients who have a Child-Pugh:A/B; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2. Exclusion Criteria: - White blood cell <3 x 10^9/L,Platelet count <75 x 10^9/L;BUN and Cr more than normal limits on 3.0 times ; - Known or suspected allergy to the investigational agent or any agent given in association with this trial; - Pregnant or lactating patients; - Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection; - Patients who are suffering from serious autoimmune disease; - Patients who had used long time or are using immunosuppressant; - Patients who had active infection; - Prior use of any anti-cancer treatment in 30 days; - Now or recently will join another experimental clinical study ; - History of organ allograft; - Other situations that the researchers considered unsuitable for this study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Yantai City Hospital for Infectious Diseases | Yantai | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shenzhen Hornetcorn Bio-technology Company, LTD | Yantai City Hospital for Infectious Diseases |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | 3 years | No | |
Secondary | Progress-free survival | 3 years | No | |
Secondary | Quality of life (QOL) | 3 years | No | |
Secondary | Phenotypic analysis of T cells | 1 years | No |
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