Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03515252|
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : May 9, 2018
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
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|