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Re-challenge of Anti-EGFR for Patients With RAS/BRAF Wild-type Metastatic CRC | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Re-challenge of Anti-EGFR for Patients With RAS/BRAF Wild-type Metastatic CRC

Re-challenge of Anti-EGFR Agents for Chinese Patients With RAS/BRAF Wild-type Metastatic Colorectal Cancer

NCT04224415•Yuhong Li

Summary

The aim of the trial is to study the efficacy and safety of Cetuximab re-challenge for Chinese Patients with RAS/BRAF wild-type Metastatic Colorectal Cancer.

Detailed Description

After first-line treatment of FOLFOX/FOLFIRI/FOLFOXIRI plus Cetuximab failure and defined as RAS/BRAF wild-type by molecular detection of cycle tumor DNA, the patients will be treated with Cetuximab and Irinotecan as a second-line or third-line treatment.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age ≥ 18 and ≤75.
•Diagnosed as colorectal adenocarcinoma by histology.
•Initially confirmed as RAS/BRAF wild type by tissue molecular detection.
•Treated with first-line therapy of FOLFOX/FOLFIRI/FOLFOXIRI+Cetuximab effectively and the PFS is not less than 6 months.
•Tumor progression during Cetuximab treatment or after treatment within 3 months.
•Tumor progression again after second-line treatment.
•The interval time of re-challenge is more than 4 months after the last time treated with Cetuximab.
•Lesions can be measured by the standard of RECIST v1.1.
•Defined as RAS/BRAF wild-type by molecular detection of cycle tumor DNA,
•No hematologic dysfunction(Platelets \>90×10\^9/L; WBC \>3×10\^9/L; Neutrophil \>1.5×10\^9/L；Hemoglobin \>10 g/100ml).
+8 more criteria

Exclusion Criteria

•RAS/BRAF mutation.
•Severe arterial embolism or ascites.
•Presence of hemorrhagic tendency or coagulation dysfunction.
•Presence of hypertensive crisis or hypertensive encephalopathy.
•Severe uncontrolled systemic complications, such as infection or diabetes.
•Severe clinical CVD(cardiovascular disease), such as cerebrovascular accident(within 6 months before recruitment), myocardial infarction(within 6 months before recruitment), uncontrolled hypertension; unstable angina pectoris; congestive heart-failure(NYHA 2-4 grade); arrhythmia that needs medication treatment.
•Previous diagnosed or physical examination showed presence of central nervous system(CNS) disease(i.e. primary brain tumor, epilepsy uncontrolled by standard treatment, any history of brain metastases or stroke).
•Previous history of other malignancy within 5 years(except basal cell carcinoma after radical resection and/or cervical carcinoma in situ).
•Received any medication under research within 28 days before the trial.
•Any residual toxicity of previous chemotherapy(except hair loss), i.e. peripheral neuropathy ≥ NCI CTC v3.0 Grade 2, will be excluded from oxaliplatin-based chemotherapy regimen research pair.
+5 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

January 31, 2020

Primary Completion Date

December 31, 2021

Completion Date

December 31, 2021

Last Updated

February 15, 2023

Enrollment

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

C225+CPT-11

DRUG

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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RECRUITINGPHASE1

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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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: February 15, 2023Data 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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Re-challenge of Anti-EGFR for Patients With RAS/BRAF Wild-type Metastatic CRC

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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