Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA: an Open, Prospective, Phase II Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Fudan University
- Enrollment
- 1,100
- Locations
- 1
- Primary Endpoint
- Detection rate of NeoRAS WT
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Metastatic colorectal cancer with tissue RAS mutation-type;
- •ECOG (Eastern Cooperative Oncology Group) performance score is 0-1;
- •Obtaining informed consent;
- •Surgical specimens or punctured tissue specimens containing tumors can be obtained; 10ml of peripheral blood can be obtained
Exclusion Criteria
- •The pathology was not confirmed by colonoscopy biopsy or biopsy of metastasis;
- •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
Arms & Interventions
RAS mutated metastatic colorectal cancer
RAS mutated metastatic colorectal cancer were routinely treated after enrollment. When the disease progression was confirmed by imaging, peripheral blood ctDNA detection was performed to observe whether they were transformed into NeoRAS wild-type patients. If NeoRAS wild- type was detected, the anti-EGFR therapy may be considered as the following therapy for patients.
Intervention: Cetuximab (Drug)
Outcomes
Primary Outcomes
Detection rate of NeoRAS WT
Time Frame: up to 60 months
Proportion of occurrence of neoRAS WT
Secondary Outcomes
- Overall survival (OS) in NeoRAS WT patients(Follow-up was conducted for 2 years after enrollment)
- Objective response rate(ORR) of NeoRAS wild-type patients receiving anti-EGFR therapy(Follow-up was conducted for 2 years after enrollment)
- Progression-free survival (PFS) in NeoRAS WT patients(Follow-up was conducted for 2 years after enrollment)
Investigators
Junjie Peng
Professor
Fudan University