UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study on the safety of preoperative comprehensive immune-cell therapy against progressive rectal cancer
Acronym	A clinical study of comprehensive immune-cell therapy against rectal cancer
Scientific Title	A clinical study on the safety of preoperative comprehensive immune-cell therapy against progressive rectal cancer
Scientific Title:Acronym	A clinical study of comprehensive immune-cell therapy against rectal cancer
Region	Japan

Condition
Condition	Rectal carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	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.
Key secondary outcomes	Efficacy

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	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.
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Sakamoto
Organization	Juntendo University Hospital
Division name	Department of Coloproctological Surgery
Zip code	113-8421
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL	03-3813-3111
Email	kazusaka@juntendo.ac.jp

Public contact
Name of contact person	1st name Kiichi Middle name Last name Sugimoto
Organization	Juntendo University Hospital
Division name	Department of Coloproctological Surgery
Zip code	113-8421
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL	03-3813-3111
Homepage URL
Email	ksugimo@juntendo.ac.jp

Sponsor
Institute	Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Nippon Medical School Hospital Fukuoka University Hospital Seta Clinic Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Juntendo University Hospital
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel	0338133111
Email	kazusaka@juntendo.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTc030190248
Org. issuing International ID_1	jRCT(Japan Registry Clinical Trials)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	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)

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 11 Month 23 Day
Date of IRB	2019 Year 03 Month 27 Day
Anticipated trial start date	2019 Year 01 Month 22 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Transition to jRCT(Japan Registry Clinical Trials).

Management information
Registered date	2019 Year 01 Month 21 Day
Last modified on	2020 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040566