colorectal cancer
Conditions
Interventions
OR7C1+IFNb
BORIS+IFNb
OR7C1+IFNa
BORIS+IFNa
Sponsors
Sapporo medical university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with a definitive diagnosis of colorectal adenocarcinoma. (2) Patients with expression of HLA class I in cancer cells. (3) Patients must meet all of the following criteria. Patients diagnosed as being impossible to remove lesions by surgery, patients who meet one of the following criteria. a) Patients who have already completed 2nd-line chemotherapy and have ceased due to refractory anticancer drugs or side effects. b) Patient who refused chemotherapy. (4) Patients with measurable lesion as determined by CT or MRI at screening period. (5) Patients with HLA-A24 or HLA-A2 positive. (6) Patients with ECOG Performance Status 0 or 1. (7) Patients without serious organ failure within 30 days prior to registration (neutrophil >=1,500/uL, hemoglobin level >=8.0 g/dL, platelet count >=75,000/uL, 1.5 times serum creatinine level <= normal upper limit level, 3 times total serum bilirubin level <= normal upper limit level, AST and ALT <=3 times normal upper limit level). (8) Patients aged 20-85 years when providing informed consent. (9) Patients who have received sufficient explanation of this trial.
Exclusion criteria
Exclusion criteria: (1) HIV positive. (2) Heart disease under NYHA III or IV classification. (3) Uncontrollablediabetes/hypertension. (4) Pleural effusion/pericardial fluid/ascites). (5) Autoimmune disease. (6) History of interstitial pneumonia. (7) Organ transplantation (including hematopoietic stem cell transplantation) (8) Life-threatening diseases. (9) History of immune cell therapy for cancer. (10) Received followingtreatmentdesignated period prior to registration. a)Surgery/radiotherapy. b)Chemotherapy. c)Endocrine therapy/immunotherapy. d)Blood transfusion/hematopoietic factor. e)Application of immunosuppressive drug. f)Investigational/unlicensed drugs. (11) Use of Sho-sai-koto/warfarin/ theophylline. (12) Steroids use required. (13) History of severe drug allergy. (14) Sensitive to cow materials. (15) Sensitive to biological preparation. (16) Severe psychosis/neurologic manifestation. (17) Pregnant/lactating. Hope to conceive during trial/unable to use contraception. (18) Disqualified for trial by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety 2) Immunological response | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Disease Control Rate 2) Progression-Free Survival | — |
Countries
Japan
Contacts
Public ContactToshihiko Torigoe
Sapporo medical university Department of Pathology(I)
Outcome results
None listed