Zinc Supplement in Regorafenib Treated mCRC Patient

Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial

Phase II randomized trial to investigate whether supplementation of zinc decreases the incidence of HFSR that occurs after treatment of tyrosine kinase inhibitor, regorafenib.

This study is aimed to investigate the effect of zinc supplementation on improving regorafenib treatment safety and efficacy in patients with metastatic colorectal cancer (mCRC). The difference in grade 2 or worse hand-foot skin reaction (HFSR) incidence within the first 8 weeks of regorafenib treatment between two arms will be examined as the primary objective.

Inclusion Criteria:

• Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib
• Ability to understand and willingness to sign written Informed Consent Form (ICF)

Exclusion Criteria:

• Patients participating in an investigational program with interventions outside of routine clinical practice
• Patients with baseline Zinc level above 120 ug/dL
• Patients with known allergy to Zinc supplementation
• Pregnancy
• Patients who are unsuitable for study participation, based on investigator's discretion