About this trial

The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

Eligibility criteria

Qualifiers

Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.

Age ≥18 years at the time of informed consent

ECOG performance status (PS) of 0-2

Written informed consent prior to study-specific screening procedures

Disqualifiers

History of other malignancy with a disease-free interval <5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)

With massive pleural effusion or ascites requiring intervention

Radiological evidence of brain tumor or brain metastases

Active infection including hepatitis

Trial design

Treatments tested in this trial

  • Bevacizumab
  • CPT-11
  • 5-FU Bolus
  • 5-FU Infusion
  • l-LV (dl-LV)

Treatment groups

280 Participants
are divided into 2 treatment groups

Locations

1
Cancer center of Sun Yat-sen University510060, GuangzhouGuangdong, China

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor