Unique ID issued by UMIN | UMIN000017350 |
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Receipt number | R000020134 |
Scientific Title | The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer |
Date of disclosure of the study information | 2015/04/30 |
Last modified on | 2017/06/20 19:57:20 |
The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer
The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer
The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer
The evaluation for safety and efficacy of combination therapy of adoptive immune-cell therapy with chemoradiotherapy for locally advanced esophageal cancer
Japan |
Locally advanced esophageal cancer
Gastroenterology | Gastrointestinal surgery | Radiology |
Malignancy
NO
To evaluate safety and efficacy about immune-cell therapy conducted concurrently with chemoradiotherapy for locally advanced esophageal cancer.
Safety,Efficacy
Pragmatic
Not applicable
Safety
Local control rate at one year
overall survival period
overall survival rate
Distant metastasis-free survival rete
QOL
immunological parameters
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
Radiation therapy
Fluorouracil(5-FU)
Cisplatin(CDDP)
Alpha-Beta T-cell Therapy
immature Dendritic cells Therapy
20 | years-old | <= |
80 | years-old | >= |
Male and Female
(1) Patient with Locally advanced esophageal cancer (T2-3N0-1M0-1a, StageII-IVA except T4; UICC)
(2) Patients can be conducted apheresis before chemotherapy
(3) Patient age of 20 to 80 years
(4) Patient with performance status 0-2
(5) Patient has more than three months of expected life time
(6) Patients with no bone-marrow, liver, and renal dysfunction
(7) Patient agrees to participate in this study with informed consent
(1) Patient with interstitial pneumonia
(2) Patient who received cancer immunotherapy
(3) Patient with active autoimmune disease
(4) Patient with active heart disease
(5) Patient with uncontrollable infectious diseases
(6) Patient with serious drug allergy
(7) Patient with uncontrollable diabetes mellitus
(8) Patient with active multiple malignancies
(9) Patient with continuous use of systemic administration of steroids
(10) Patient with severe psychological disorders
(11) Patient in pregnancy
(12) Patient positive for HIV or HTLV-1
(13) Current participation in other drug clinical trials. (excluding the study, which doesn't need intervention)
(14) Patients who are inadequate to enter this study due to the other reasons by physician's judgments
6
1st name | |
Middle name | |
Last name | Takashi Nakano |
Gunma University
Department of Radiation Oncology, Gunma University Graduate School of Medicine
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
027-220-8383
tnakano@gunma-u.ac.jp
1st name | |
Middle name | |
Last name | Shin-ei Noda |
Gunma University
Department of Radiation Oncology, Gunma University Graduate School of Medicine
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
027-220-8383
snoda@gunma-u.ac.jp
Gunma University
Ministry of Health, Labour and Welfare
NO
群馬大学(群馬県)
2015 | Year | 04 | Month | 30 | Day |
Unpublished
Terminated
2014 | Year | 11 | Month | 01 | Day |
2014 | Year | 11 | Month | 01 | Day |
2015 | Year | 04 | Month | 30 | Day |
2017 | Year | 06 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020134
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