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

JRCT ID: jRCT1050230049

Registered date:24/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 24/06/2023
• Target sample size: 240
• Study type: Observational

Outcome(s)

• Primary Outcome: Progression-free survival in ctDNA RAS/BRAF wild and mutant
• Secondary Outcome: 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,

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kozo Kataoka
• Secondary Sponsor: Sysmex
• Secondary ID(s): Nil known