Unique ID issued by UMIN | UMIN000001417 |
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Receipt number | R000001729 |
Scientific Title | The efficacy and safety of autologous gamma/delta T cell transfer therapy after resection of intrahepatic cholangiocarcinoma or biliary tract cancer |
Date of disclosure of the study information | 2008/10/08 |
Last modified on | 2016/01/29 12:42:36 |
The efficacy and safety of autologous gamma/delta T cell transfer therapy after resection of intrahepatic cholangiocarcinoma or biliary tract cancer
Autologous gamma/delta T cell therapy after resection of intrahepatic cholangiocarcinoma or biliary tract cancer
The efficacy and safety of autologous gamma/delta T cell transfer therapy after resection of intrahepatic cholangiocarcinoma or biliary tract cancer
Autologous gamma/delta T cell therapy after resection of intrahepatic cholangiocarcinoma or biliary tract cancer
Japan |
Intrahepatic cholangiocarcinoma
biliary tract cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To investigate efficacy and safety of autologous gamma/delta T cell transfer therapy after resection of intrahepatic cholangiocarcinoma or biliary tract cancer.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Relapse free survival
Recurrence rate (1 and 2 years)
Overall survival
Response rate
Survival rate (3 and 5 years)
Response of tumor-related markers
Immunological responses
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
Gamma/delta T cells are injected on day0, day14, day28, day42, day56, day70, day84, day98.
Gemcitabine on day-3, day4, day11, day25, day32, day39, day53, day60, day67, day81, day88, day95.
20 | years-old | <= |
Not applicable |
Male and Female
Intrahepatic cholangiocarcinoma or biliary tract cancer patients who received surgical resection:
- Pathological diagnosis of intrahepatic cholangiocarcinoma or biliary tract cancer;
- High risk of recurrence (positive lymph node, positive margin or multiple intrahepatic cancer);
- Life-expectancy is more than 3 months;
- Performance status is 0-1;
- No serious abnormality in heart, lung, bone marrow, liver, and renal functions.
Patients who have:
- Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them;
- Active enteritis;
- Active autoimmune diseases;
- Active infections;
- Other cancers;
- Other serious complications;
- Continuous systemic administration of steroids.
30
1st name | |
Middle name | |
Last name | Norihiro Kokudo |
The University of Tokyo Hospital
Department of Hepatobiliary Pancreatic Surgery and Department of Artificial Organ and Transplantation Surgery
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
03-5800-8654
1st name | |
Middle name | |
Last name | Kazuhiro Kakimi |
Graduate School of Medicine, The University of Tokyo
Department of Immunotherapeutics
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
03-5805-3161
immunotherapy-admin@umin.ac.jp
The University of Tokyo Hospital
Medinet Co.,Ltd.
Profit organization
Japan
NO
2008 | Year | 10 | Month | 08 | Day |
Partially published
Presented by The 48th Annual Meeting of Japan Sopciety of Hepatology.
Completed
2008 | Year | 09 | Month | 16 | Day |
2008 | Year | 09 | Month | 01 | Day |
2015 | Year | 07 | Month | 31 | Day |
2008 | Year | 10 | Month | 08 | Day |
2016 | Year | 01 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001729
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