This is a prospective, open-lable, multicenter, randomized, controlled, phase II clinical study. The aim is to evaluate the efficacy of Irinotecan versus Oxaliplatin in the first-line treatment of refractory metastatic colorectal cancer.
Name: Irinotecan
Description: Irinotecan 180 mg / m2, intravenous drip, D1, combined with fluorouracil / calcium folinate or Capecitabine or S1; combine or not combine with Bevacizumab or Cetuximab; every 14 days for a cycle.Type: DrugIrinotecan-based chemotherapy
Name: Oxaliplatin
Description: Oxaliplatin 85mg/m2 (two-week regimen) or 130mg/m2 (three week regimen), intravenous drip, D1, combined with fluorouracil / calcium folinate or Capecitabine or S1; combine or not combine with Bevacizumab or Cetuximab; every 14 or 21 days for a cycle.Type: DrugOxaliplatin-based chemotherapy
Description: Evaluation of the Progression-free Survival of Irinotecan-based regimen versus Oxaliplatin-based regimen in refractory metastatic colorectal cancer patients.
Measure: Progression-free Survival: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first. Time: assessed up to 10 monthsDescription: Evaluation of the Overall Survival of Irinotecan-based regimen versus Oxaliplatin-based regimen in refractory metastatic colorectal cancer patients.
Measure: Overall Survival : From date of enrollment until the date of death. Time: 2 yearsDescription: flurouracil drugs：fluorouracil、S1、Capecitabine
Measure: Evaluation of PFS in patients with different fluorouracil drugs and different genotyping subgroups. Time: 10monthsDescription: flurouracil drugs：fluorouracil、S1、Capecitabine
Measure: Evaluation of OS in patients with different fluorouracil drugs and different genotyping subgroups. Time: 2 yearsDescription: Adverse reactions evaluation is based on the National Cancer Institute adverse event General terminology Standard [CTCAE] 4.0 version
Measure: The incidence of treatment related emergent adverse events（Safety and Tolerance） Time: Until 28 days after the deadline of enrollmentAllocation: Randomized
Parallel Assignment
There is one SNP
3. Subjects with BRAF V600E mutation. --- V600E ---