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.
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.
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.
Parallel
mCapOX plus Cetuximab
DrugmCapOX plus Cetuximab Induction therapy：Capecitabine 1000mg/m2 po, bid, D1-7 + Oxaliplatin ivgtt 85mg/m2, D1 + Cetuximab ivgtt 500mg/m2, D1; Q2W. Up to 12 cycle, if no progression, enter maintenance therapy. Maintenance therapy: Capecitabine 1000mg/m2 po, bid, D1-7 + Cetuximab ivgtt 500mg/m2, D1; Q2W. Until disease progression or toxicity is not tolerated. Cetuximab can be discontinued alone if not tolerated. Treatment after progression of maintenance therapy: Participants have the option to accept reintroducing the first-line induction chemotherapy regimen (mCapOx or mFOLFOX6 in combination with cetuximab) or accept second-line therapy.
mFOLFOX6 plus Cetuximab
DrugmFOLFOX6 plus Cetuximab Induction therapy：Oxaliplatin ivgtt 85mg/m2, D1 + Leucovorin ivgtt 400mg/m2, D1 + Fluorouracil iv bolus 400mg/m2, D1 + Fluorouracil 2400mg/m2 continuous infusion for 46-48h + Cetuximab ivgtt 500mg/m2, D1; Q2W. Up to 12 cycle, if no progression, enter maintenance therapy. Maintenance therapy: Capecitabine 1000mg/m2 po, bid, D1-7 + Cetuximab ivgtt 500mg/m2, D1; Q2W. Until disease progression or toxicity is not tolerated. Cetuximab can be discontinued alone if not tolerated. Treatment after progression of maintenance therapy: Participants have the option to accept reintroducing the first-line induction chemotherapy regimen (mCapOx or mFOLFOX6 in combination with cetuximab) or accept second-line therapy.
Progression free survival (PFS)
Progression free survival is defined as the period from randomization to disease progress or death. Includes first-line induction therapy and maintenance therapy.
Objective Response Rate (ORR)
Defined as the proportion of participants acquired Complete response (CR) or Partial response (PR) during treatment. Based on RECIST 1.1.
Disease control rate (DCR)
Defined as the proportion of patients who acquired Complete response (CR), Partial response (PR), or Stable disease (SD) during treatment. Based on RECIST 1.1.
Time to Failure of Strategy (TFS)
Defined as the time from the date of randomization to \[secondary disease progression after reintroduction of first-line induction chemotherapy following maintenance therapy disease progression\] or \[all-cause death\]. If participants progressed on maintenance therapy after first-line induction chemotherapy without reintroduction of first-line induction chemotherapy or progressed during first-line induction chemotherapy, TFS equals PFS
Overall Survival (OS)
Defined as the period from randomization to death from any cause
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Meng Qiu
Lead sponsor
West China Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
