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

NCT03124498 | Unknown Phase 1

• 1 other identifier: CABIO-CIK-1701
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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

Keywords

Hepatocellular Carcinoma, Autologous Cytokine-Induced Killer

Outcome Measures

Primary Outcomes (2)

• Phase I: Presence or absence of Dose-Limiting Toxicity

  5 Weeks

• Phase II: Disease Control Rate

  24 Weeks

Study Arms (1)

CIK Cell

EXPERIMENTAL

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

Interventions

CIK Cell BIOLOGICAL

Autologous cytokine-induced killer (CIK) cell

CIK Cell

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years old men and women;
• HCC diagnosed with typical imaging findings, or confirmed by needle liver biopsy;
• Patients who are not a transplant candidate;
• Patients who have no extrahepatic metastasis and are with measurable residual tumor after TACE, PEIT or RFA therapy;
• Patients who have a life expectancy of at least 6 months;
• Child-Pugh Class should be A or B;
• Eastern Cooperative Oncology Group (ECOG) performance status score was 0-3;
• 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

You may not qualify if:

• Patients who have infiltrative or diffuse HCC;
• Patients who have significant cardiovascular disease such as myocardial infarction occurred within recent 6 months, chronic heart failure or unstable coronary artery disease;
• Patients who plan to receive systemic chemotherapy or target therapy;
• Patients with other malignant tumor within the past 5 years before treatment;
• Pregnant or lactating patients;
• Patients with hemorrhage/bleeding event;
• Patients with uncontrolled infections;
• Known or suspected allergy to the investigational agent or any agent given in association with this trial;
• Patients who have current Human Immunodeficiency Virus (HIV) or Treponema Pallidum (TP) infection;
• Patients who are suffering from serious autoimmune disease;
• Patients who have had long term use of or are using an immunosuppressant;
• History of organ transplant;
• Prior use of any anti-cancer treatments within 30 days or 5 half-lives (whichever is longer), except TACE, PEIT and RFA therapy;
• Patients who have participated in another clinical study and received treatment within 30 days prior to the screening visit;
• Mental conditions rendering the patient incapable of understanding the nature, scope, and consequences of the study;

Sponsors & Collaborators

• Chuan An Biotechnology Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Keanyee Lai

CONTACT

+886-02-27928987; laikeanyee@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 21, 2017
• Study Start: November 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 21, 2017

Record last verified: 2017-04