Phase I and Pharmacokinetic Study of Biweekly PEP02 in mCRC Refractory to 1st-line Oxaliplatin Base Therapy

Inclusion Criteria: * Histopathologically confirmed metastatic colorectal cancer * Documented disease progression after first-line chemotherapy containing oxaliplatin * Both genders, age 18 years * ECOG performance status 0 or 1 * Adequate organ and marrow function * Written informed consent to participate in the study Exclusion Criteria: * Have received irinotecan treatment * With active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth) * With clinically significant gastrointestinal disorder (e.g. bleeding, inflammation, obstruction, including partial or complete obstruction secondary to peritoneal carcinomatosis, or diarrhea \> grade 1) * With uncontrolled intercurrent illness that could limit study compliance considered to be ineligible for the study by the investigators including, but NOT limited to, any of the following:ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia psychiatric illness or social situation that would preclude study compliance * With other primary malignancies, except those remain disease-free for 3 or more years after curative treatment. * Prior chemotherapy within 3 weeks * Major surgery or radiotherapy within 4 weeks * Prior participation in any investigational drug study within 3 weeks * History of allergic reaction to liposome product * Pregnant or breastfeeding (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative)