Unique ID issued by UMIN | UMIN000035608 |
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Receipt number | R000040566 |
Scientific Title | A clinical study on the safety of preoperative comprehensive immune-cell therapy against progressive rectal cancer |
Date of disclosure of the study information | 2019/01/21 |
Last modified on | 2020/05/25 10:33:25 |
A clinical study on the safety of preoperative comprehensive immune-cell therapy against progressive rectal cancer
A clinical study of comprehensive immune-cell therapy against rectal cancer
A clinical study on the safety of preoperative comprehensive immune-cell therapy against progressive rectal cancer
A clinical study of comprehensive immune-cell therapy against rectal cancer
Japan |
Rectal carcinoma
Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Malignancy
NO
This study aims at evaluating the safety, efficacy and immunological response by combination of adjuvant integrated immune-cell therapy for progressive rectal cancer patients with immune-cell therapy using activated lymphocytes and chemotherapy using mFOLFOX6.
Safety
Exploratory
Phase I,II
This study aims at evaluating the safety by combination of adjuvant integrated immune-cell therapy for progressive rectal cancer patients with immune-cell therapy using activated lymphocytes and chemotherapy using mFOLFOX6.
Efficacy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
mFOLFOX6 (Levofolinate 200 mg/m2, L-OHP 85 mg/m2, 5-FU/bolus 400 mg/m2, 5-FU/continuous 2,400 mg/m2)
Alpha beta T cell therapy
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Patient musy be diagnosed as adenocarcinoma pathologically including papillary adenocarcinoma, tubular adenocarcinoma, anaplastic adenocarcinoma, colloid carcinoma, signet ring cell adenocarcinoma and medullar cancer, by endoscopic biopsy from primary lesion in rectum.
2) Tumor must exist in either Ra or Rb mainly.
3) Patient must be included one criteria below:
a) diagnosed as above cT3 by either abdominal or pelvis contrast-enhanced CT or contrast-enhanced MRI.
b) diagnosed as above cN1, that is, lymph mode metastasis has detected by pelvis contrast-enhanced CT with slice thickness of below 5mm. However, patient of cT4b must be excluded if infiltration is suspected to either trigon of bladder, urethra or sacred bone.
4) Patient must be diagnosed bas cM0, that is, distant metastases have not been detected by either chest CT, abdominal or pelvis contrast-enhanced CT or contrast enhanced MRI of slice thickness of below 5mm
5) Patient must be between 20 and 80 years old at registration.
6) Patient must be 0, 1 of ECOG PS score.
7) Patient must have no previous chemotherapy, no proctectomy, but local excision, no pelvis lymphadenectomy for any cancers.
8) Patient must not have multicentric cancer according to comprehensive diagnosis using colonoscopy and imaging, that is barium enema examination or abdomen/pelvis contrast-enhanced CT, or CT colonography.
9) Test results within 14 days before the registration satisfies all the requirements
10) Either abdominal operation or laparoscopic surgery must be planned.
11) Patient must have given written consent to the study
1) Patient must not have active multiple cancer. Active multiple cancer means concurrent multiple cancer or multi centric cancer and non-concurrent multiple or multi centric cancer which has intervals within 5 years without disease.
However carsinoma in situ and intramucosal carcinoma are not included in active cancer as they are curable by local treatment.
2) Patient must not have infectious disease which requires systemic therapy.
3) Patient must not be HIV positive, nor HTLV-1 positive.
4) Patient must not be microsatellite instability (MSI) positive.
5) Patient must not have fever over 38 degrees centigrade at registration.
6) Pregnant woman, woman possible to be pregnant, woman within 28 days after delivery and nursing woman must be excluded.
7) Patient that has mental disorders or neurologic manifestation must be excluded.
8) Patient that continuous whole body oral or intravenous administration of steroid or other immunosuppressive drug
9) Patient that has one or mutiple of diseases among interstitial pneumonia, pulmonary fibrosis, intense pneumonectasia diagnosed by chest CT must be excluded..
10) Patient that has active autoimmune disease must be excluded.
11) Patient that has diabetes either during continuous insulin treatment or under poor control must be excluded.
12) Patient that has insecurity angina pectoris, that is, angina pectoris which occurs or aggravates within 3 weeks, and patient that has previous heart infarction within 6 months.
13) Patient that doctor(s), either principal researcher or member of the project has judged inappropriate to join this study must be excluded.
6
1st name | Kazuhiro |
Middle name | |
Last name | Sakamoto |
Juntendo University Hospital
Department of Coloproctological Surgery
113-8421
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
03-3813-3111
kazusaka@juntendo.ac.jp
1st name | Kiichi |
Middle name | |
Last name | Sugimoto |
Juntendo University Hospital
Department of Coloproctological Surgery
113-8421
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
03-3813-3111
ksugimo@juntendo.ac.jp
Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
None
Self funding
Japan
Nippon Medical School Hospital
Fukuoka University Hospital
Seta Clinic Tokyo
Juntendo University Hospital
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
0338133111
kazusaka@juntendo.ac.jp
YES
jRCTc030190248
jRCT(Japan Registry Clinical Trials)
順天堂大学医学部附属順天堂医院
日本医科大学付属病院
福岡大学病院
Juntendo University Hospital(Tokyo)
Nippon Medical School Hospital(Tokyo)
Fukuoka University Hospital(Fukuoka)
2019 | Year | 01 | Month | 21 | Day |
Unpublished
Terminated
2018 | Year | 11 | Month | 23 | Day |
2019 | Year | 03 | Month | 27 | Day |
2019 | Year | 01 | Month | 22 | Day |
2020 | Year | 12 | Month | 31 | Day |
Transition to jRCT(Japan Registry Clinical Trials).
2019 | Year | 01 | Month | 21 | Day |
2020 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040566
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