First-line Treatment of MCapOX + Cetuximab Vs. MFOLFOX6 + Cetuximab for RAS/BRAF Wild-type, MSS, Unresectable Left-Sided MCRC: a Multicenter, Randomized, Controlled, Phase III Study

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMeng Qiu

About this trial

This multicenter, randomized, controlled, phase III study is conducted to evaluate the efficacy and safety of first line mCapOX plus Cetuximab versus mFOLFOX6 plus Cetuximab for RAS/BRAF wild-type, MSS, Unresectable Left-Sided mCRC.

Eligibility criteria

Qualifiers

Able to provide written informed consent and can understand and comply with the requirements of the study.

Men and women ≥ 18 years of age.

Patients with histologically or cytologically confirmed RAS and BRAF wild-type, MSS/pMMR, metastatic left-sided colorectal adenocarcinoma.

Presence of at least one evaluable lesion, as defined in RECIST Version 1.1.

Disqualifiers

Patients with mCRC who were initially resectable with R0 resection or radiofrequency or SBRT were excluded.

Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry

Hypersensitivity to any therapeutic agent.

Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study.

Trial design

Treatments tested in this trial

  • mCapOX plus Cetuximab
  • mFOLFOX6 plus Cetuximab

Treatment groups

452 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Meng Qiu

Lead sponsor

West China Hospital

Sponsor institution