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

NCT ID: NCT03124498

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2019-06-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CIK Cell

Phase I - Three dose levels escalated according to 3+3 rule

Phase II - The recommended dose level according to the results from Phase I

Group Type: EXPERIMENTAL

CIK Cell

Intervention Type: BIOLOGICAL

Autologous cytokine-induced killer (CIK) cell

Interventions

CIK Cell

Autologous cytokine-induced killer (CIK) cell

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chuan An Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Keanyee Lai

Role: CONTACT

laikeanyee@gmail.com

+886-02-27928987

Other Identifiers

CABIO-CIK-1701

Identifier Type: -

Identifier Source: org_study_id