Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA

Phase 2

Recruiting

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: Cetuximab

• Registration Number: NCT06440902
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-28
• Study First Submitted: 2024-02-22
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04
• Primary Completion: 2028-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RAS mutated metastatic colorectal cancer	Cetuximab	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.

Primary Outcome Measures

Name	Time	Method
Detection rate of NeoRAS WT	up to 60 months	Proportion of occurrence of neoRAS WT

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China