Hepatocellular Carcinoma (HCC)
Conditions
Keywords
Hepatocellular carcinoma, DC-CIK
Brief summary
The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).
Detailed description
About 60 patients with HCC, who had received complete resection or TACE and got Complete remission (CR) or partial response (PR), will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.
Interventions
Sponsors
Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients \> 18 years of age; 2. Hepatocellular carcinoma with histological or imaging and AFP diagnose, and had received complete resection or TACE and got CR or PR by imaging studies; 3. Patients who have a life expectancy of at least 12 weeks; 4. Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1; 5. The bone marrow functioned normally (WBC \> 4.0×109/L, Hb \> 120 g/L, PLT \> 100×109/L); 6. The ECG results were normal, and the liver and kidney were functional.
Exclusion criteria
1. Patients who had distant metastases; 2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening; 3. Patients who were pregnant or lactating; 4. ECOG perform status ≥ 2; 5. Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS) | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS) | 1 month |
| quality of life (QOL) | month |
Other
| Measure | Time frame |
|---|---|
| Laboratory findings | 1 month |
Countries
China
Contacts
Primary ContactHanfeng Liu
Outcome results
None listed