Table 2.
Eligibility criteria for the LICC-trial
| • Metastases other than liver metastases. |
|---|
| • R2 and Rx resected liver metastases. Patients with R1 resected liver metastases can be included if a further surgical resection is seen as not indicated or necessary in the surgeon's opinion. |
| • Chemotherapy within 4 weeks prior to randomization. |
| • Receipt of immunotherapy (e.g. interferons, tumor necrosis factor, interleukins, or growth factors [GM-CSF, G-CSF, M- CSF], monoclonal antibodies) within 4 weeks (28 days) prior to randomization. |
| • Any known autoimmune disease, past or current. |
| • A recognized immunodeficiency disease including cellular immuno-deficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficiencies. |
| • Known or newly diagnosed active hepatitis B infection and/or hepatitis C infection, autoimmune hepatitis, known human immunodeficiency virus infection, or any other infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response, or expose him/her to likelihood of more and/or severe side effects. |
| • Past or current history of malignant neoplasm other than CRC, except for curatively treated non-melanoma skin cancer, in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years. |
| • Medical or psychiatric conditions that would interfere with ability to provide informed consent, communicate side effects, or comply with protocol requirements. |
| • Clinically significant cardiac disease, e.g. cardiac failure of New York Heart Association classes III-IV; uncontrolled angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension, myocardial infarction in the previous 12 months as confirmed by an ECG. |
| • Splenectomy. |
| • Previous (less than 4 weeks prior to randomization) or concurrent treatment with a non-permitted drug. |
| • Pregnancy and lactation period. |
| • Participation in another clinical study within 30 days prior to randomization. |
| • Known hypersensitivity to the study treatment drugs. |
| • Known alcohol or drug abuse. |
| • Legal incapacity or limited legal capacity. |
| • Any other reason that, in the opinion of the investigator, precludes the patient from participating in this study. |
Exclusion criteria