Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases

Inclusion criteria

• Histopathologically confirmed complete resection (R0) of liver metastases from colorectal adenocarcinoma
• Age ≥18 years
• ECOG performance status ≤ 2
• Patient was informed, has read and understood the patient information / informed consent form and has given written informed consent

Exclusion criteria

• Extra-hepatic distant metastases or locally recurrent disease at time of enrolment
• Neoadjuvant chemotherapy of liver metastases prior to surgery
• Any anticancer chemotherapy within 4 weeks prior to study entry
• Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry
• Any biological anticancer therapy or immunotherapy within 4 weeks prior to study entry
• Any radiotherapy or radio frequency ablation (RFA) to the liver prior to surgery
• Treatment with any investigational product within a time range of 4-5 half-lives (t½) prior to study entry
• Acute or chronic pancreatitis or history of alcohol induced pancreatitis
• Liver cirrhosis, acute hepatitis or chronic hepatic disease
• Any unresolved complications from prior surgery
• Persistent neuropathy
• History of other malignancy within 5 years prior to study start, with the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix and Ductal Carcinoma in Situ (DCIS)
• History of inflammatory bowel disease
• Active severe infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
• Use of immune-suppressive agents such as the regular use of systemic corticosteroids
• HIV positivity
• Known hypersensitivity or intolerability to immunoglobulins in general, other recombinant human or humanized antibodies, Folinic Acid, 5-Fluorouracil, Oxaliplatin or a component of the study drug formulations, known dihydropyrimidine dehydrogenase (DPD) deficiency
• Pregnant or nursing women
• Women of childbearing potential or male patients not willing to use an effective form of contraception during treatment phase of the study and at least 6 months thereafter
• Not willing or incapable to comply with all study visits and assessments
• Placed into an institution due to juridical or regulatory ruling