Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, Autologous Cytokine-Induced Killer
Brief summary
A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients with Hepatocellular Carcinoma (HCC) after Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy.
Interventions
BIOLOGICALCIK Cell
Autologous cytokine-induced killer (CIK) cell
Sponsors
Chuan An Biotechnology Co., Ltd.
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 20 to 80 years old men and women; 2. HCC diagnosed with typical imaging findings, or confirmed by needle liver biopsy; 3. Patients who are not a transplant candidate; 4. Patients who have no extrahepatic metastasis and are with measurable residual tumor after TACE, PEIT or RFA therapy; 5. Patients who have a life expectancy of at least 6 months; 6. Child-Pugh Class should be A or B; 7. Eastern Cooperative Oncology Group (ECOG) performance status score was 0-3; 8. Patients who have clinical laboratory test results as follows: * Absolute neutrophil count ≥ 1,500/µL or White blood cell ≥ 4,000/µL * Hemoglobin ≥ 8.5 g/dL * Platelet count ≥ 50,000/µL * Blood creatinine ≤ 1.5 x upper limit of normal * Total bilirubin \< 3 x upper limit of normal * Albumin ≥ 2.8 g/dL * International normalized ratio (INR) / Partial thromboplastin time (PTT) \< 1.5 x upper limit of normal 9. Written informed consent.
Exclusion criteria
1. Patients who have infiltrative or diffuse HCC; 2. Patients who have significant cardiovascular disease such as myocardial infarction occurred within recent 6 months, chronic heart failure or unstable coronary artery disease; 3. Patients who plan to receive systemic chemotherapy or target therapy; 4. Patients with other malignant tumor within the past 5 years before treatment; 5. Pregnant or lactating patients; 6. Patients with hemorrhage/bleeding event; 7. Patients with uncontrolled infections; 8. Known or suspected allergy to the investigational agent or any agent given in association with this trial; 9. Patients who have current Human Immunodeficiency Virus (HIV) or Treponema Pallidum (TP) infection; 10. Patients who are suffering from serious autoimmune disease; 11. Patients who have had long term use of or are using an immunosuppressant; 12. History of organ transplant; 13. Prior use of any anti-cancer treatments within 30 days or 5 half-lives (whichever is longer), except TACE, PEIT and RFA therapy; 14. Patients who have participated in another clinical study and received treatment within 30 days prior to the screening visit; 15. Mental conditions rendering the patient incapable of understanding the nature, scope, and consequences of the study; 16. Other situations that the researchers considered unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Presence or absence of Dose-Limiting Toxicity | 5 Weeks |
| Phase II: Disease Control Rate | 24 Weeks |
Contacts
Primary ContactKeanyee Lai
Outcome results
None listed