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

Hepatocellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01024530
• Other study ID #: IVY02
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 1, 2009
• Last updated: December 11, 2009
• Start date: May 2009

Study information

• Verified date: December 2009
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Center for Drug EvaluationTaiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer

Intervention

Biological:
• immune killer cells (IKC)
autologous immune killer cells

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital	Ivy Life Sciences, Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Measure: Reduction of tumor size		Two years	No
Secondary	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)		Two years	No