A clinical study on the safety of preoperative comprehensive immune-cell therapy against progressive rectal cancer
- Conditions
- Rectal carcinoma
- Registration Number
- JPRN-UMIN000035608
- Lead Sponsor
- Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Efficacy