A Study to Evaluate Autologous CIK Cells in Patients With Hepatocellular Carcinoma After TACE, PEIT or RFA

Chuan An Biotechnology

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Biological: CIK Cell

Study type: Interventional

Funder types: Industry

Identifiers

NCT03124498

CABIO-CIK-1701

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

55 participants in 1 patient group

CIK Cell

Experimental group

Description:

Phase I - Three dose levels escalated according to 3+3 rule Phase II - The recommended dose level according to the results from Phase I

Treatment:

Biological: CIK Cell