Colorectal Cancer Metastatic
Conditions
Brief summary
Following systemic therapy in metastatic colorectal cancer(mCRC),RAS (including KRAS, NRAS and HRAS gene) status may change from a mutant(MT) to a wild-type(WT),a phenomenon known as NeoRAS WTmCRC.NeoRAS WT can be detected by longitudinal circulating tumor DNA(ctDNA) analysis.Therefore, this prospective phase II Study was design to explore the detection rate of peripheral blood ctDNA testing for NeoRAS WT and its guiding value for subsequent treatment for mCRC.
Interventions
DRUGCetuximab
Cetuximab is given In patients with NeoRAS WT
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Metastatic colorectal cancer with tissue RAS mutation-type; 2. ECOG (Eastern Cooperative Oncology Group) performance score is 0-1; 3. Obtaining informed consent; 4. Surgical specimens or punctured tissue specimens containing tumors can be obtained; 10ml of peripheral blood can be obtained
Exclusion criteria
1. The pathology was not confirmed by colonoscopy biopsy or biopsy of metastasis; 2. Colorectal cancer patients with clinical stage I-III;Patients with RAS wild-type metastatic colorectal cancer confirmed by histological genetic testing;Lack of adequate organ functions, such as severe abnormalities in blood, liver and kidney function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of NeoRAS WT | up to 60 months | Proportion of occurrence of neoRAS WT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) of NeoRAS wild-type patients receiving anti-EGFR therapy | Follow-up was conducted for 2 years after enrollment | Objective response rate of NeoRAS wild-type patients receiving anti-EGFR (epidermal growth factor receptor) therapy |
| Progression-free survival (PFS) in NeoRAS WT patients | Follow-up was conducted for 2 years after enrollment | Progression-free survival (PFS) : time from enrollment to disease progression from any cause |
| Overall survival (OS) in NeoRAS WT patients | Follow-up was conducted for 2 years after enrollment | Overall survival (OS) : time from enrollment to death from any cause, loss of participants, and time of last follow-up |
Countries
China
Contacts
Primary ContactJunjie Peng, PhD
Outcome results
None listed