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
Recruitment status was Recruiting
Sponsor:
Shin Kong Wu Ho-Su Memorial Hospital
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
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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：
- Reduction of tumor size
- 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:
- Sign and give written informed consent.
- Age≧20 years, but＜80 years.
- Hepatocellular carcinoma by CT, MRI, AFP, angiography or cytology/biopsy examinations.
- Barcelona staging system stage B and C.
- Never receive TACE treatment and comply with the standard of TACE treatment.
- Child-Pugh stage A and B.
- ECOG performance status 0 to 2.
Exclusion Criteria:
- Participant of other clinical trial within the past 4 weeks of screening period.
- Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
- Carriers of HIV or HTLV within the past 4 weeks of screening period.
- With Active acute or chronic infection（by investigator's judgement）.
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）.
- Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
Contacts and Locations
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 Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma |
ClinicalTrials.gov processed this record on May 19, 2013