Study on 5-Fluorouracil/Leucovorin and Regorafenib for Metastatic Colorectal Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have confirmed metastatic colorectal cancer.
• Have not responded to second-line treatment for metastatic cancer.
• Have at least one tumor that can be measured.
• Be in good overall health with an ECOG performance status of 0 or 1.
• Have a life expectancy of at least 6 months.
• Be able to understand and sign a consent form.
• Have adequate bone marrow, liver, and kidney function based on specific lab tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
• Men and women of childbearing potential must agree to use contraception during the study and for 2 months after the last dose.
• Must be able to swallow pills.

Exclusion Criteria

• Have low blood cell counts or abnormal liver function tests.
• Have a positive pregnancy test or are breastfeeding.
• Have significant heart problems or recent heart attack.
• Have active infections or other serious medical conditions.
• Have a history of other cancers within the last 3 years, except for certain skin or cervical cancers.
• Have received certain vaccines or treatments recently.
• Have uncontrolled high blood pressure.
• Have a history of bleeding disorders or recent significant bleeding events.
• Have untreated or active brain tumors.
• Have had major surgery recently.
• Have a history of organ transplant.
• Have allergies to study drugs.
• Have any condition that makes participation unsafe according to the investigator.