A Phase I/II Trial of TS-1 and Oxaliplatin in Patients With Advanced Colorectal Cancer

Subjects meeting all of the following criteria will be considered for enrolment into the study. 1. Histologically documented colorectal adenocarcinoma 2. Previous chemotherapy up to two regimens(including adjuvant chemotherapy and first-line chemotherapy without oxaliplatin) is allowed in phase I portion; patients are required to have discontinued chemotherapy and/or radiotherapy for at least 4weeks before entry into phase I portion. No prior chemotherapy or radiotherapy allowed(adjuvant chemotherapy and/or radiotherapy would be allowed) in phase II portion 3. Age 18 to 75 years old 4. At least one unidimensional measurable lesion with a diameter \>20 mm using conventional CT or MRI scans or \>10 mm using spiral CT scans (use of spiral CT must be documented in medical records and used consistently throughout study). 5. In phase I study, prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before study entry. 6. Performance status (ECOG scale): 0-2 7. Patients can take food and drugs orally 8. Adequate organ functions 9. Life expectancy ≥ 3 months 10. Written informed consent