Second-line Treatment of Metastatic Colorectal Cancer
Trial Parameters
Brief Summary
The goal of this multicenter, single-arm, observational cohort study is to investigate the efficacy and safety of irinotecan in combination with trifluridine-tipiracil and bevacizumab in colorectal cancer with prior oxaliplatin and fluoropyrimidine-based chemotherapy (including 5-FU/capecitabine/S-1) exposure in the metastatic setting or within 12 months of recurrence.
Eligibility Criteria
Inclusion Criteria: 1. All subjects are required to sign an informed consent form before starting the study-related procedure 2. Age 18-75 years old, male or female. 3. have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1, life expectancy \>3 months. 4. Histologically or cytological proven metastatic or recurrent adenocarcinoma of the colon or rectum. 5. Prior treatment with a fluoropyrimidine (5-fluorouracil \[5-FU\] or capecitabine) and oxaliplatin with bevacizumab or cetuximab targeted therapy as the first-line regimen. 6. Recurrence or metastasis within 12 months after completion of adjuvant/neoadjuvant therapy with oxaliplatin and fluoropyrimidine-based drugs is also considered as the failure of first-line chemotherapy. 7. At least one measurable metastatic lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 8. Adequate organ function: bone marrow, kidney, liver function (within 7 days before treatment start) Absolute neutrophi