CCaLM: Investigating the efficacy of an Adjuvant immunotherapy for preventing colorectal liver metastases - The CCaLM trial

This study is looking to perform a double blinded randomised controlled trial for patients with primary colon adenocarcinoma (cancer) with the use of a monoclonal antibody (Labetuzumab) targeting receptors in the liver which may form liver metastases.

Who is it for?
You may be eligible for this study if you are an adult with suspected or confirmed colon adenocarcinoma (on histopathology) who is undergoing surgical resection at St George Hospital, Sydney.

Study details
Participants will undergo blood and tissue testing to determine if they are at low or high risk for developing liver metastases of their colon adenocarcinoma. Patients in the high-risk group will be randomly allocated to either an active treatment group, who will receive an intravenous infusion of Labetuzumab every other day during the month following their surgical resection, or a placebo group who will receive infusions of normal saline only. Data regarding the development of metachronous (> 6 months from primary operation) liver metastases related to their primary colon cancer will be collected from all patients in this study.

It is hoped that findings from this study will help inform a multicentric, multinational trial investigating this treatment for patients affected by colon cancer that are at risk of it spreading to their liver and causing unresectable or terminal disease to follow.