NCT06204484: MIRROR

MRD-guided Deferred Adjuvant Therapy in Resectable Early-stage Colon Cancer

Recruiting now NA Last updated 12 January 2024

What this trial tests

NA trial testing CAPEOX adjuvant therapy in Colorectal Cancer in 349 participants. Currently enrolling.

Timeline

26 July 2023

Primary endpoint
31 July 2028

31 July 2028

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	349
Start date	26 July 2023
Primary completion	31 July 2028
Estimated completion	31 July 2028
Sites	1 location across China

Drugs / interventions tested

• CAPEOX adjuvant therapy
• deferred CAPEOX adjuvant therapy
• mFOLFOXIRI intensive adjuvant therapy

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this clinical trial is to test whether minimal residual disease (MRD) status detected by circulating tumor DNA (ctDNA) could be used to guide precision therapy of post-surgery in colon cancer. The colon cancers are intended for resectable colon cancer of high-risk stage II and low-risk stage III status. The main questions it aims to answer are:

1. Whether patients with MRD negative status could benefit from deferred adjuvant therapy.
2. Whether patients with MRD positive status need intensive adjuvant therapy. The qualified participants will go through two different randomized groups according to the post-surgery 1-month MRD status. In MRD negative groups, participants will be divided into standard adjuvant therapy groups and deferred adjuvant therapy groups at 1:2 ratios. In MRD positive groups, participants will be divided into standard adjuvant therapy groups and intensive adjuvant therapy groups at 1:2 ratios. All the patients will receive MRD detection every 3 months and radiological evaluation every 6 months up to 3 years, and survival follow-up up to 5 years.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical utility and future perspectives of liquid biopsy in colorectal cancer.
   Patelli G, Lazzari L, Crisafulli G, Sartore-Bianchi A, et al · · 2025 · cited 7× · PMID 40275061 · DOI 10.1038/s43856-025-00852-4
2. Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing.
   Kobayashi S, Nakamura Y, Hashimoto T, Bando H, et al · · 2025 · cited 6× · PMID 39920551 · DOI 10.1007/s10147-024-02683-0