Unique ID issued by UMIN | UMIN000005929 |
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Receipt number | R000007010 |
Scientific Title | Clinical study of autologous tumor lysate-pulsed dendritic cell therapy for advanced colorectal cancer (Stage3, 4) |
Date of disclosure of the study information | 2011/07/05 |
Last modified on | 2015/01/05 12:11:38 |
Clinical study of autologous tumor lysate-pulsed dendritic cell therapy for advanced colorectal cancer (Stage3, 4)
Clinical study of autologous tumor lysate-pulsed dendritic cell therapy for advanced colorectal cancer (Stage3, 4)
Clinical study of autologous tumor lysate-pulsed dendritic cell therapy for advanced colorectal cancer (Stage3, 4)
Clinical study of autologous tumor lysate-pulsed dendritic cell therapy for advanced colorectal cancer (Stage3, 4)
Japan |
colorectal cancer (Stage3, 4)
Gastrointestinal surgery |
Malignancy
NO
To investigate safety and efficacy on combination therapy of autologous tumor lysate-pulsed dendritic cells and standard adjuvant chemotherapy for advanced colorectal cancer (Stage3, 4)
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Safety
Immunological responses
Antitumor effect
progression-free survival
event-free survival
overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Vaccine |
Patients of stage 3a recieved UFT+l-LV(
day1-28) and autologous tumor lysate-pulsed dendritic cells (day8,22) every 2 weeks.This treatment repeats 6 courses, or recieved capecitabine (day1-14) and autologous tumor lysate-pulsed dendritic cells (day8) every 2 weeks.This treatment repeats 5 courses,
Patients of 3b and/or 4 received FOLFOX or FOLFOX+ bevacizumab (day1-3) and autologous tumor lysate-pulsed dendritic cells (day8) every 2 weeks.
This treatment repeats 6 courses.
20 | years-old | <= |
Not applicable |
Male and Female
Colorectal cancer patients who are histopathologically diagnosed as Stage3b or 4 and adenocarcinoma;
(1)Tumor tissue is preserved after resection and tumor lysate is aseptically prepared;
(2)No serious abnormality in heart, lung, bone marrow, liver, and renal functions;
(3)Performance Status is 0-1;
(4)Apheresis is feasibile.
Patients who have:
(1)Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them
(2)Serious drug allergy
(3)Serious cardiac disease
(4)Active autoimmune disease
(5)Other cancers
(6)Drainage is necessary (pleural/ascites effusion )
(7)Brain metastasis with symptoms
(8)Edema which needs treatment
(9)Positive for HIV or HTLV-1
(10)Continuous systematic administration of steroids within 4 weeks (20mg or more on a predonine conversion basis)
(11)Uncontrollable infection
(12)Pregnant or lactating
(13)Gelling of plasma, cryoglobulinemia
(14)Any reason why, in the opinion of the investigator, the patient should not participate.
15
1st name | |
Middle name | |
Last name | Hiroshi Shiroma |
Tomishiro Central Hospital
Department of Surgery
25,Azaueta,Tomishiro,Okinawa,Japan
1st name | |
Middle name | |
Last name | Atsushi Ochiai |
Tomishiro Central Hospital
Office of Clinical Trial
202-1-293 azagibo, tomigusukushi, Okinawa , Japan
Tomishiro Central Hospital
Tomishiro Central Hospital
Self funding
NO
2011 | Year | 07 | Month | 05 | Day |
Unpublished
Completed
2011 | Year | 06 | Month | 30 | Day |
2011 | Year | 07 | Month | 01 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 11 | Month | 15 | Day |
2014 | Year | 11 | Month | 30 | Day |
2014 | Year | 12 | Month | 31 | Day |
2011 | Year | 07 | Month | 05 | Day |
2015 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007010
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