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

RECRUITINGPHASE2

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

First-line Treatment of mCapOX Plus Cetuximab Versus mFOLFOX6 Plus Cetuximab for Metastatic Left-sided CRC Patients With Wild-type RAS/BRAF Genes: a Multicenter, Randomised, Phase 2 Study

NCT05022030•West China Hospital

View on ClinicalTrials.gov

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.

Detailed Description

The patients, who meet the inclusion criteria and have signed the informed consent, will be randomly assigned (1:1 ratio) to receive mCapOX plus cetuximab regimen (arm A) and mFOLFOX6 plus cetuximab regimen (arm B).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 metastatic left-sided colorectal adenocarcinoma with wild-type RAS and BRAF genes;
•Presence of at least one evaluable lesion, as defined in RECIST Version 1.1;
•With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
•No palliative first-line chemotherapy, targeted, immunotherapy, or prior platinum-based adjuvant chemotherapy, relapse more than 12 months from the end of adjuvant chemotherapy;
•According to the imaging findings and surgical assessment of initial unresectable, synchronous metastatic colorectal cancer, no serious complications of the primary tumor (obstruction, perforation, massive hemorrhage that cannot be treated in internal medicine, etc.) ;
•Life expectancy of longer than 3 months ( clinical assessment);
•Requirements for lab indicators neutrophils ≥ 1.5 × 109/L, platelets ≥ 75 × 109/L, hemoglobin ≥ 8 g/dL, total bilirubin ≤ 1.5 × upper limit of normal (UNL); ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases); alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases, ≤ 10 × UNL if bone metastases); LDH \< 1500 U/L; creatinine clearance (calculated according to Cockcroft and Gault formula) \> 50 mL/min or serum creatinine ≤ 1.5 × UNL;

Exclusion Criteria

•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;
•Patients who have failed one or more palliative chemotherapy regimens;
•Patients with uncontrolled hepatitis B virus
•Peripheral neuropathy ≥ CTC grade 2;
•Neurological or psychiatric disorders affecting cognitive performance;
•Patients with central nervous system metastasis could not be controlled with radiotherapy;
•Previous enteritis, chronic diarrhea, or recurrent bowel obstruction; uncontrolled bleeding from internal medicine; bowel perforation
+6 more criteria

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

July 21, 2021

Primary Completion Date

June 1, 2025

Completion Date

June 1, 2026

Last Updated

March 7, 2024

Enrollment

150

ESTIMATED participants

Conditions

Colo-rectal CancerCapecitabineCetuximab

Interventions

mCapOX plus cetuximab

DRUG

mFOLFOX6 plus cetuximab

DRUG

Contacts

Xiaofen Li, M.D.

CONTACT

+86-28-85422589 lxf0827@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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