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Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX For CRCLM

NCT03493048 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-08-03

No results posted yet for this study

Summary

The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis of RAS wildtype. The patients will be treated in two therapy groups:

Experimental arm A: Chemotherapy with FOLFOXIRI + Cetuximab Standard arm B: Chemotherapy with FOLFOX + Cetuximab

Conditions

Interventions

DRUG

Irinotecan

Irinotecan 130 mg/m²

DRUG

Cetuximab

Cetuximab, iv, 500mg/m2

DRUG

5-fluorouracil

5-FU 2400 mg/m² cont. inf.

DRUG

Oxaliplatin

oxaliplatin 85 mg/m²

DRUG

Leucovorin

leucovorin 200 mg/m²

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yuhong Li · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2022-12-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03493048 on ClinicalTrials.gov