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

Phase 1

• Conditions: Hepatocellular Carcinoma
• Interventions: Biological: CIK Cell

• Registration Number: NCT03124498
• Lead Sponsor: Chuan An Biotechnology Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Study First Posted: 2017-04-21
• Last Update Posted: 2017-04-21
• Study Start: 2017-11
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CIK Cell	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

Primary Outcome Measures

Name	Time	Method
Phase I: Presence or absence of Dose-Limiting Toxicity	5 Weeks
Phase II: Disease Control Rate	24 Weeks