JPRN-jRCT1050230049
Recruiting
未知
Observational study to evaluate the impact of heterogeneities of RAS/BRAF in tissue and ctDNA on the efficacy of anti EGFR antibody in advanced colorectal cancer - RAS-trace 2
Kozo Kataoka0 sites240 target enrollmentJune 24, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- colorectal cancer
- Sponsor
- Kozo Kataoka
- Enrollment
- 240
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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