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

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 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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Biological: CIK Cell

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Keanyee Lai; Phone Number: +886-02-27928987; Email: laikeanyee@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: CIK Cell; Autologous cytokine-induced killer (CIK) cell

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chuan An Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma, Autologous Cytokine-Induced Killer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: CABIO-CIK-1701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No