RALOX or CAPOX + Bevacizumab in the First-line Treatment of Advanced CRC(ROCB Study)
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Raltitrexed is an inhibitor of thymidylate synthase.As a folate antimetabolite drug,
raltitrexed has been used in treatment of colorectal cancer(CRC) since 1998, and also used in
malignant mesothelioma.Several phase III studies performed in patients with advanced CRC
showed that it is as effective as 5-fluorouracil(5-FU) /leucovorin(LV) with regard to
response rates and survival. The combination of raltitrexed with oxaliplatin shows response
rates of 41%-54% and median survivals of 14.6-14.8 months, which are comparable to those
achieved with 5-FU/LV combination with oxaliplatin. This study discussed the efficacy and
safety of raltitrexed-oxaliplatin(RALOX) combined with bevacizumab or
capecitabine-oxaliplatin(CAPOX) combined with bevacizumab in first-line treatment of patients
with advanced colorectal cancer who could not undergo radical surgery. The main endpoint will
be progression free survival (PFS). The secondary endpoints will be overall survival,
objective response rate and disease control rate (OS,ORR and DCR).It is expected that
raltitrexed may be one of options for the treatment of advanced CRC in the first-line
setting.