A Phase II Prospective Trial of mXELOXIRI Reintroduction for mCRC

Inclusion Criteria

• •1. Personal written informed consent is obtained after the study has been fully explained
• •2. Histologically confirmed colon or rectal adenocarcinoma
• •\*Excluding appendix cancer and anal canal cancer
• •3. Clinically unresectable
• •4. Borderline resectable liver metastases of colorectal cancer considered to have poor-risk disease not deemed to be suitable for upfront resection if they had one or more of the following features assessed by a local multidisciplinary team: more than four metastases, location and distribution of metastatic disease within the liver unsuitable for resection with clear margins (e.g. involvement of both lobes of liver, invasion of intrahepatic vascular structures), extent of liver involvement precluding resection with adequate post-resection residual liver parenchyma volume for viable liver function in the immediate postoperative period, and inability to retain adequate vascular inflow and outflow to maintain viable liver function.
• •5. Age at enrollment is \>= 18 and \<= 75 years
• •6. Life expectancy of at least 12 weeks.
• •7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
• •8. .Vital organ functions meet the following criteria within 14 days before enrollment.
• •If multiple test results are available in that period, the results closest to enrollment will be used. No blood transfusions or hematopoietic factor administration will be permitted within 2 weeks before the date on which measurements are taken.
• •i. Absolute neutrophil count (ANC): ≥3,000 /cu.mm ii. Platelet count: ≥10.0 × 104/cu.mm iii. Hemoglobin concentration: ≥8.0 g/dL iv. Prothrombin time (PT), activated partial thromboplastin time(APTT): ≤1.5 times upper limit of normal (ULN) v. Total bilirubin: ≤1.5 times ULN (≤3 times ULN for metastases to liver).Aspartate aminotransferase (AST), Alanine aminotransferase (ALT): ≤2.5 times ULN (≤5 times ULN for metastases to liver).vi. Serum creatinine: ≤1.5 times ULN, or creatinine clearance: ≥30 mL/min