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.
Study participants who meet the enrollment criteria will be randomly assigned in a 1:1 ratio to either the mCapOX + cetuximab or mFOLFOX6 + cetuximab treatment groups, and those who have achieved control of their disease (Complete response \[CR\] + Partial response \[PR\] + Stable disease \[SD\]) after a maximum of 12 cycles of first-line induction therapy in both groups will continue to receive Capecitabine or Capecitabine + Cetuximab maintenance therapy until disease progression or toxicity is not tolerated or informed consent is withdrawn.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
452
mCapOX 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 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.
West China Hospital Sichuan University
Chengdu, Sichuan, China
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.
Time frame: up to 3 years
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.
Time frame: 6 months
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 frame: 6 months
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
Time frame: up to 3 years
Overall Survival (OS)
Defined as the period from randomization to death from any cause
Time frame: up to 5 years
Adverse Event rate
The rate of adverse event after treatment
Time frame: up to 3 years
Pharmacoeconomic
Including CERs (Cost-Effectiveness Ratios) and ICERs (Incremental Cost-Effectiveness Ratios). CERs:Defined as the ratio of the total costs of a medical intervention to the health benefits gained from that intervention. ICERs:Defined as the ratio of the difference in costs between two alternative interventions(Arm A and Arm B) to the difference in their effectiveness.
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Time frame: up to 3 years
Quality of Life
Assessment of quality of life through the Quality of Life Questionnaire (QLQ)
Time frame: up to 3 years