Clinical trial NCT03124498: A Study to Evaluate Autologous CIK Cells in Patients With Hepatocellular Carcinoma After TACE, PEIT or RFA
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma, Autologous Cytokine-Induced Killer
Lead sponsor: Chuan An Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-21
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Phase I: Presence or absence of Dose-Limiting Toxicity
timeFrame: 5 Weeks
measure: Phase II: Disease Control Rate
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: