Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy

HepatoCellular Carcinoma Clinical Trial

Official title:

A Phase II/III Clinical Trial With Ex Vivo Expanded Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03592706
• Other study ID #: IVY02
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 2009
• Est. completion date: August 2021

Study information

• Verified date: April 2020
• Source: Ivy Life Sciences, Co., Ltd
• Contact: Executive Assistant
• Phone: (02)8981-3333
• Email: thesteve[@]ivy-cd56.com
• Is FDA regulated: No
• 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.

Description:

This is a phase II/III clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of twelve infusions.

60 patients are anticipated to be recruited. This is a double-arm study, the experimental group will receive IKC treatment along with TACE treatment. The control group will receive only TACE treatment. 30 patients will be randomized into each arm.

Other known NCT identifiers

• NCT01024530

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• 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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HepatoCellular Carcinoma
• Liver Cancer
• Liver Neoplasms

Intervention

Biological:
• IKC (Immune Killer Cells)

Procedure:
• TACE (Transcatheter Arterial Chemoembolization)

Locations

Country	Name	City	State
Taiwan	Tri Service General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Ivy Life Sciences, Co., Ltd	Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of tumor size	Evaluate the efficacy of autologous immune killer cells using Response Evaluation Criteria in Solid Tumors (RECIST) by recording net changes of tumor sizes	One year
Primary	Progression-Free Survival (PFS)	The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse	One year
Secondary	Improvement of immune responses	Evaluate the efficacy and safety of in vitro proliferating autoimmune killer cells as adjuvant therapy for the treatment of liver cancer patients and promote anti-cancer immune responses	One year