The impact of heterogeneities of RAS/BRAF in tissue and ctDNA on the efficacy of anti EGFR antibody in advanced colorectal cancer

Not Applicable

Recruiting

• Conditions: colorectal cancer; RAS BRAFwild coloretal cancer; D015179

• Registration Number: JPRN-jRCT1050230049
• Lead Sponsor: Kozo Kataoka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1)Histologically proven for colorectal cancer
2)Clinical Stage IV or recurrent colorectal cancer for which more than 12 cycles of chemotherapy including anti-EGFR therapy is planned.
3)measurable lesions according to RECIST ver1.1
4)Presence of liver metastases
5) No previous history of chemotherapy and radiotherapy
6)Aged 20 years old and over
7)ECOG PS0-1
8)Consent for blood exam for ctDNA analy
9)Written informed consen

Exclusion Criteria

1)Active other malignancies
2)Histologically confirmed for MMRD (MSI-H or dMMR)
3)Pregnancy, possible pregnancy or breastfeeding
4)Severe pulmonary fibrosis or emphysema
5)Psychiatric disease
6)Patients requiring systemic steroid medication
7) Grade 2 or greater diarrhea or sensory neuropathy
8)Poorly controlled hypertension
9)History of severe heart disease, heart failure, unstable angina within 6 months or angina attack with 6 months
10) active COVID-19 infection

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival in ctDNA RAS/BRAF wild and mutant

Secondary Outcome Measures

Name	Time	Method
Response rate in ctDNA RAS/BRAF wild and mutant, overall survival, adverse event, frequency of ctDNA mutant, exploratory analysis of registant genes for anti EGFR therapy, frequency of RAS/BRAF ctDNA mutant when patients are refractory for anti-EGFR therapy, integrated analysis with RAS-trace 1, response rate, progression-free survival and overall survival in left-sided colorectal cancer patients with ctDNA RAS/BRAF wild and mutant, and response rate, progression-free survival and overall survival in colorectal cancer liver metastases with ctDNA RAS/BRAF wild and mutant,