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

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



Sponsors


Source

Chuan An Biotechnology Co., Ltd.

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2017-11-01

Completion Date

2019-06-01

Primary Completion Date

2019-06-01

Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

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

Enrollment

55

Condition


Intervention

Intervention Type

Biological

Intervention Name


Description

Autologous cytokine-induced killer (CIK) cell

Arm Group Label

CIK Cell


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.

Gender

All

Minimum Age

20 Years

Maximum Age

80 Years

Healthy Volunteers

No


Overall Contact

Last Name

Keanyee Lai

Phone

+886-02-27928987

Email



Verification Date

2017-04-01

Lastchanged Date

2017-04-19

Firstreceived Date

2017-04-19

Responsible Party

Responsible Party Type

Sponsor


Keyword


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

CIK Cell

Arm Group Type

Experimental

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


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Sequential Assignment

Primary Purpose

Treatment

Masking

No masking



ClinicalTrials.gov processed this data on April 21, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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