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First-line mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab for Metastatic Left-sided CRC With Wild-type RAS/BRAF Genes

NCT05022030 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-03-07

No results posted yet for this study

Summary

This prospective, randomized, phase 2 study is conducted to evaluate the efficacy and safety of first line mCapOX plus cetuximab versus mFOLFOX6 plus cetuximab for metastatic left-sided CRC patients with wild-type RAS and BRAF genes.

Conditions

  • Colo-rectal Cancer
  • Capecitabine
  • Cetuximab

Interventions

DRUG

mCapOX plus cetuximab

capecitabine 1000mg/m2 po bid d1-7+oxaliplatin ivgtt 85mg/m2 d1+cetuximab ivgtt 500mg/m2, q2w

DRUG

mFOLFOX6 plus cetuximab

oxaliplatin ivgtt 85mg/m2 d1+ leucovorin ivgtt 400mg/m2 d1+ fluorouracil iv bolus 400mg/m2 d1+ fluorouracil 2400mg/m2 continuous infusion for 46h+cetuximab ivgtt 500mg/m2, q2w

Sponsors & Collaborators

  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • West China Hospital

    lead OTHER

Principal Investigators

  • Meng Qiu, M.D. · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2025-06-01
Completion
2026-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022030 on ClinicalTrials.gov