Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases (MT201-204)

This is an interventional treatment trial for Liver Metastases focused on measuring Colorectal carcinoma, Liver metastases (only), R0 resection, R0 resection of liver metastases from colorectal cancer Read More

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