FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients

Phase III Study of Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) Versus Irinotecan Monodrug as Second-line Treatment in Metastatic Colorectal Cancer Patients

This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.

Inclusion Criteria:

• aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
• Eastern Cooperative Oncology Group performance status of 0 to 2
• life expectancy of ≥ 3 months
• patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
• at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
• have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

• patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
• patients with symptomatic brain metastases
• active clinical severe infection
• previously received irinotecan
• dihydropyrimidine dehydrogenase (DPD) enzyme adequate