Cetuximab Plus Capecitabine as Maintenance Treatment in RAS and BRAF wt Metastatic Colorectal Cancer
Status:
Not yet recruiting
Trial end date:
2024-03-30
Target enrollment:
Participant gender:
Summary
This is an open-label, multicenter, randomized study to be conducted in Chinese patients with
RAS and BRAF wild-type mCRC. Patients who have already completed 9 cycles of standard
first-line induction treatment, without discontinuation for toxicity, of cetuximab or
fluorouracil or oxaliplatin,, and achieved disease control (including CR/PR and SD), and are
progression free at the end of Cycle 9 will be assigned to 2 maintenance treatment groups by
randomization in a 1:1 ratio to receive cetuximab + capecitabine (Arm A) or cetuximab alone
(Arm B). The randomization will be stratified by induction treatment response (complete
response [CR]+ partial response [PR] versus stable disease [SD]) and primary tumor location
(left side only versus right side). All patients from Arm A and Arm B will be treated until
progressive disease, death from any cause, unacceptable toxicity or informed consent
withdrawal (whichever occurs earlier).