Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03515252 |
Recruitment Status :
Completed
First Posted : May 3, 2018
Last Update Posted : May 9, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
NSCLC Stage IIIB NSCLC Stage IV Hepatocellular Carcinoma by BCLC Stage Lung Cancer Liver Cancer | Biological: Immune Killer Cells (IKC) | Phase 1 |
This is a phase I 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 six infusions.
For each indication (cancer of the lung or liver) 10 patients are anticipated to be recruited, making a total of 20 subjects. All subjects will receive treatment as this is a single-arm study.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study to Evaluate the Safety and Efficacy of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer |
Actual Study Start Date : | April 26, 2005 |
Actual Primary Completion Date : | November 2, 2006 |
Actual Study Completion Date : | June 7, 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Late stage lung cancer and liver cancer
Immune Killer Cells (IKC)
|
Biological: Immune Killer Cells (IKC) |
- Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: 5 months ]Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded and evaluated for their relationship to the treatment
- Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 4 months ]Record net changes of tumor sizes
- Quality of Life (QOL) [ Time Frame: 5 months ]
The assessment will be performed using The World Heath Organization Quality of Life Questionnaire (WHOQOL)
This questionnaire produces a quality of life profile. It is possible to derive four domain scores. The four domain scores denote an individual's perception of quality of life in each particular domain (1. Physical health 2. Psychological 3. Social relationships 4. Environmental) Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
The mean score of items within each domain is used to calculate the domain score (min: 0 max: 100)
Domain scores are then calculated (divide domain score by 4) to produce a final QOL Score (i.e. higher scores denote higher quality of life min: 0 max:100).

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, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- subjects had voluntarily given written informed consent
- subjects had CT scan on lung or liver tumors within the past 4 weeks of the screening visit
- subjects who were histologically or pathologically confirmed with locally advanced or metastatic lung cancer or HCC
- subjects who did not have valid therapy, ever failed with other therapy, or refused or were not appropriate for other therapies for lung cancer or HCC
- subjects' ECOG performance status ≤ 2
- subjects with life expectancy ≥ 3 months
Exclusion Criteria:
- subjects with medical history of gout
- subjects who had participated other clinical trials within 4 weeks before the screening visit
- subjects with positive result of HIV or HTLV test within 4 weeks before the screening visit
- subjects with clinically significant diseases other than cancer
- subjects with myocardial infraction, stroke, or congestive heart failure within 3 months before the screening visit
- female subjects who were pregnant or lactating or women of child-bearing potential but unable to take adequate contraception
- subjects with history of alcohol, drug or other substance abuse
- subjects with disease of bacteremia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515252
Principal Investigator: | Kuo-Ching Yang, MD, PhD | Shin Kong Wu Ho-Su Memorial Hospital |
Responsible Party: | Ivy Life Sciences, Co., Ltd |
ClinicalTrials.gov Identifier: | NCT03515252 |
Other Study ID Numbers: |
IVY 01 |
First Posted: | May 3, 2018 Key Record Dates |
Last Update Posted: | May 9, 2018 |
Last Verified: | April 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Lung Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Digestive System Diseases Liver Diseases |