NCT06616259

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

First-line Treatment of MCapOX in Combination with Cetuximab Versus MFOLFOX6 in Combination with Cetuximab for RAS/BRAF Wild-type, MSS, Unresectable Left-Sided Metastatic Colorectal Cancer: a Multicenter, Randomized, Controlled, Phase III Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (estimated)
• Sponsor: Meng Qiu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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+ Cetuximab maintenance therapy until disease progression or toxicity is not tolerated or informed consent is withdrawn.

Conditions

• Colorectal Cancer (CRC)
• Capecitabine
• Cetuximab

Interventions

Type	Name	Description
DRUG	mCapOX plus Cetuximab	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.
DRUG	mFOLFOX6 plus Cetuximab	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.

Timeline

• Start date: 2024-09-26
• Primary completion: 2028-09-30
• Completion: 2029-09-30
• First posted: 2024-09-27
• Last updated: 2024-09-27

Locations

1 site across 1 country: China