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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03124498
• Other study ID #: CABIO-CIK-1701
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: April 19, 2017
• Last updated: April 19, 2017
• Start date: November 2017
• Est. completion date: June 2019

Study information

• Verified date: April 2017
• Source: Chuan An Biotechnology Co., Ltd.
• Contact: Keanyee Lai
• Phone: +886-02-27928987
• Email: laikeanyee[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• CIK Cell
Autologous cytokine-induced killer (CIK) cell

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chuan An Biotechnology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Presence or absence of Dose-Limiting Toxicity		5 Weeks
Primary	Phase II: Disease Control Rate		24 Weeks