Unique ID issued by UMIN | UMIN000001966 |
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Receipt number | R000002400 |
Scientific Title | Clinical study of a combined use of EGFR-TKI and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer. |
Date of disclosure of the study information | 2009/05/13 |
Last modified on | 2013/04/08 10:00:49 |
Clinical study of a combined use of EGFR-TKI and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer.
Clinical study of a combined use of EGFR-TKI and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer.
Clinical study of a combined use of EGFR-TKI and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer.
Clinical study of a combined use of EGFR-TKI and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer.
Japan |
non-small cell lung cancer
Pneumology |
Malignancy
NO
To investigate efficacy and safety on LAK therapy for non-small cell lung cancer patients whose anti-tumor effect of EGFR-TKI is SD or PD.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Antitumor effect
Progression-free survival
Overall survival
Survival rate
Improvement of tumor-related markers
QOL(FACT-BRM)
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Autologous Lymphocyte-Activated Killer cells (LAK) are injected on day0,day14,day28,day42,day56,day70.
EGFR-TKI regulated dosage,regimen/day,oral daily.
20 | years-old | <= |
Not applicable |
Male and Female
Non-small cell lung cancer patients who are judged SD or PD for EGFR-TKI therapy based on RECIST
Patients who have measurable lesion
-Performance Status is 0-1
-Life-expectancy is more than 4 months.
-No serious abnormality in bone marrow, liver and/or renal functions
Patients who have:
-Previous history of hypersensitivity to EGFR-TKI
-Uncontrolled infections
-Active autoimmune diseases
-Serious cardiac disease
-Continuous systemic administration of steroids.
-Other cancer
who are pregnant, to be pregnant, or nursing mothers, and whom principle investigator or co-investigator judged to be inappropriate to participate in this study.
10
1st name | |
Middle name | |
Last name | Kazuhisa Takahashi |
Juntendo University, School of Medicine
Department of Respiratory Medicine
2-1-1 Hongo,Bunkyo-Ku,Tokyo
03-3813-3111
1st name | |
Middle name | |
Last name | Yoshiteru Morio |
Juntendo University, School of Medicine
Department of Respiratory Medicine
2-1-1 Hongo,Bunkyo-Ku,Tokyo
03-5802-1063
ymorio@juntendo.ac.jp
Juntendo University, School of Medicine
Medinet Co.,Ltd
Profit organization
Japan
Seta Clinic Group
NO
2009 | Year | 05 | Month | 13 | Day |
Unpublished
Completed
2009 | Year | 03 | Month | 30 | Day |
2009 | Year | 05 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2009 | Year | 05 | Month | 13 | Day |
2013 | Year | 04 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002400
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