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Trial Title:
Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA
NCT ID:
NCT06440902
Condition:
Colorectal Cancer Metastatic
Conditions: Official terms:
Colorectal Neoplasms
Cetuximab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Cetuximab is given In patients with NeoRAS WT
Arm group label:
RAS mutated metastatic colorectal cancer
Other name:
C225
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 WT"mCRC.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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Junjie Peng, PhD
Phone:
+86 13917373312
Email:
pengjj@shca.org.cn
Start date:
December 28, 2023
Completion date:
September 1, 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06440902
