Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen Research (Munich) GmbH
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
