Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring EGFR, KRAS, tumor sideness, FOLFIRI, regorafenib, metastatic colorectal cancer
Eligibility Criteria
Inclusion Criteria:
- Age between 20-85 years old
- Histologically proven metastatic colorectal cancer (mCRC).
- Patients with progressing mCRC who were previously treated with FOLFOX, FOLFIRI, anti-VGFR monoclonal antibody (MoAb), and anti-EGFR MoAb if KRAS-wild-type tumors were identified.
- Patient was able to understand the requirements of the study and written informed consent was obtained from each subject.
Exclusion Criteria:
- Patients who do not meet the including criteria or unwilling to participate
Sites / Locations
- Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Arms of the Study
Arm 1
Experimental
Regorafenib plus FOLFIRI
Regimen for treatment consists of irinotecan (180 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7); 120 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA7/TA7)), followedby Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks. After every 2 cycles of each different dose of irinotecan, if adverse events (AEs) are under the grade 2, we will escalate the dose of 30 mg/m2. The estimated maximal dose of irinotecan is 260 mg/m2 for UGT1A1 genotyping (TA6/TA6); 240 mg/m2 for UGT1A1 genotyping (TA6/TA7); 180 mg/m2 for UGT1A1 genotyping (TA7/TA7). Regorafenib is administered at adjusted doseage of 120 mg daily for 3 weeks in a 4-week cycle.