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Trial record 2 of 242358 for:    ALL

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Chuan An Biotechnology Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Chuan An Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03124498
First received: April 19, 2017
Last updated: NA
Last verified: April 2017
History: No changes posted
  Purpose
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.

Condition Intervention Phase
Hepatocellular Carcinoma
Biological: CIK Cell
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Sequential Assignment
Masking: No masking
Primary Purpose: Treatment
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

Further study details as provided by Chuan An Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • Phase I: Presence or absence of Dose-Limiting Toxicity [ Time Frame: 5 Weeks ]
  • Phase II: Disease Control Rate [ Time Frame: 24 Weeks ]

Estimated Enrollment: 55
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03124498

Contacts
Contact: Keanyee Lai +886-02-27928987 laikeanyee@gmail.com

Sponsors and Collaborators
Chuan An Biotechnology Co., Ltd.
  More Information

Responsible Party: Chuan An Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03124498     History of Changes
Other Study ID Numbers: CABIO-CIK-1701
Study First Received: April 19, 2017
Last Updated: April 19, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chuan An Biotechnology Co., Ltd.:
Hepatocellular Carcinoma, Autologous Cytokine-Induced Killer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 21, 2017