Phase II/III Trial of Hepatocellular Carcinoma Patients Treated by ex Vivo Expanded Autologous Immune Killer Cells as the Adjunct Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ivy Life Sciences, Co., Ltd
Information provided by:
Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01024530
First received: December 1, 2009
Last updated: December 11, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in:

  1. Reduction of tumor size
  2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.

Condition Intervention Phase
Hepatocellular Carcinoma
Liver Cancer
Biological: immune killer cells (IKC)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Shin Kong Wu Ho-Su Memorial Hospital:

Primary Outcome Measures:
  • Outcome Measure: Reduction of tumor size [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1.All cause survival rate 2.The relapse rate: frequency of TACE treatment 3.Reduction of AFP value 4.Improvement of VAS scale and QOL(Quality of life) [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biological treament
autologous immune killer cells plus TACE(Transcatheter Arterial Chemoembolization)
Biological: immune killer cells (IKC)
autologous immune killer cells
Sham Comparator: TACE (Transcatheter Arterial Chemoembolization) Biological: immune killer cells (IKC)
autologous immune killer cells

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign and give written informed consent.
  2. Age≧20 years, but<80 years.
  3. Hepatocellular carcinoma by CT, MRI, AFP, angiography or cytology/biopsy examinations.
  4. Barcelona staging system stage B and C.
  5. Never receive TACE treatment and comply with the standard of TACE treatment.
  6. Child-Pugh stage A and B.
  7. ECOG performance status 0 to 2.

Exclusion Criteria:

  1. Participant of other clinical trial within the past 4 weeks of screening period.
  2. Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
  3. Carriers of HIV or HTLV within the past 4 weeks of screening period.
  4. With Active acute or chronic infection(by investigator's judgement).
  5. Other diseases, except hepatocellular carcinoma, which are life-threatening to the patients(by investigator's judgement)for example:

    5.1 Active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.

    5.2 With previous history of encephalopathy within the past six months. 5.3 Involved Involving systemically or known central nerve system diseases(brain or meningeal metastasis).

  6. Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
  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: NCT01024530

Locations
Taiwan
Shin Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Hui Jiun Chen    886966149672      
Principal Investigator: Kuo Ching Yang         
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Ivy Life Sciences, Co., Ltd
  More Information

No publications provided

Responsible Party: Wang Tien-Chin, IVY LIFE SCIENCES CO.,LTD
ClinicalTrials.gov Identifier: NCT01024530     History of Changes
Other Study ID Numbers: IVY02
Study First Received: December 1, 2009
Last Updated: December 11, 2009
Health Authority: Taiwan: Center for Drug Evaluation
Taiwan: Department of Health

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
hepatocellular carcinoma
HCC
NK
immune killer cells

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

ClinicalTrials.gov processed this record on September 16, 2014