Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was:  Recruiting
Ivy Life Sciences, Co., Ltd
Information provided by:
Shin Kong Wu Ho-Su Memorial Hospital Identifier:
First received: December 1, 2009
Last updated: December 11, 2009
Last verified: December 2009

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

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 ]

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 ]

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


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01024530

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

Responsible Party: Wang Tien-Chin, IVY LIFE SCIENCES CO.,LTD Identifier: NCT01024530     History of Changes
Other Study ID Numbers: IVY02
Study First Received: December 1, 2009
Last Updated: December 11, 2009

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

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 26, 2017