Abstract 511TiP
Background
Considering the efficacy and safety of capecitabine and cetuximab as potent agent for maintenance therapy from previous studies, evaluation on the efficacy of cetuximab in combination with capecitabine as a potential maintenance regimen for RAS and BRAF wild-type mCRC patients is warranted. This abstract describes the design of this study.
Trial design
The phase III, open-label, multicentre, randomized study will evaluate the efficacy and safety of cetuximab plus capecitabine among Chinese patients with RAS and BRAF WT mCRC. Patients ≥18 years, with histologically or cytologically confirmed adenocarcinoma of colon or rectum with RAS and BRAF wild-type, will be included. A total of 348 patients who have already completed 9 cycles of FOLFOX+cetuximab will be randomized in a 1:1 ratio to two maintenance treatment, Arm A (cetuximab: IV 500mg/m2, D1 every 2 weeks+capecitabine: orally 850 mg/m2 BID, D1–10 in 2-week cycles) and Arm B (cetuximab: IV 500mg/m2, D1 every 2 weeks). The randomization will be stratified by induction treatment response (CR+PR vs. SD) and tumour location (only left side vs. right side). All patients will be followed-up until progression (at least 247 events) or completion of study treatment (∼24 months after randomization of last patient) or death from any cause or unacceptable toxicity or informed consent withdrawal, whichever occurs earlier. Primary objective is to evaluate whether cetuximab plus capecitabine can prolong maintenance progression-free survival compared with cetuximab alone. Primary endpoint is maintenance PFS. Other efficacy endpoint is OS. Safety endpoint is incidence of adverse events, drug exposure, safety laboratory assessments, etc. Efficacy endpoints will be compared between the two maintenance regimens. Log-rank test, stratified cox-proportional hazards regression model and Kaplan-Meier method will be performed for PFS. Efficacy endpoints were compared using two-sided stratified log-rank test. Superiority of Arm A to Arm B in terms of mPFS can be concluded if two-sided p value <0.05.
Clinical trial identification
NCT04262635.
Editorial acknowledgement
Legal entity responsible for the study
Dr Ruihua Xu, Department of Medical Oncology, Sun Yat-sen University Cancer Hospital.
Funding
Funded by Merck Serono, Co. Ltd., China; an affiliate of Merck KGaA, Darmstadt, Germany.
Disclosure
All authors have declared no conflicts of interest.