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

Last updated: May 28, 2024
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Cetuximab

Clinical Study ID

NCT06440902
ctDNA-neoRASCRC
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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-typemetastatic colorectal cancer confirmed by histological genetic testing;Lack ofadequate organ functions, such as severe abnormalities in blood, liver and kidneyfunction

Study Design

Total Participants: 1100
Treatment Group(s): 1
Primary Treatment: Cetuximab
Phase: 2
Study Start date:
December 28, 2023
Estimated Completion Date:
September 01, 2028

Connect with a study center

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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