A clinical study of comprehensive immune-cell therapy against rectal cancer.

JRCT ID: jRCTc030190248

Registered date:16/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Progressive rectal cancer
• Date of first enrollment: 01/04/2019
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

blood collection for cell culture and tests.
Administration of therapeutic cells 6 times.

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Efficacy, Immunological response, Postoperative complications

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Sakamoto Kazuhiro