NCT06204484

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

The Effectiveness of Deferred Adjuvant Therapy Guided by Dynamic Monitoring Minimal Residue Disease in Resectable High-risk Stage II and Low-risk Stage III Colon Cancer: an Open-label, Multicenter, Phase II Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 349 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	CAPEOX adjuvant therapy	In MRD-/+ standard therapy groups, patients will receive 3-month CAPEOX therapy, regardless of the MRD status.
OTHER	deferred CAPEOX adjuvant therapy	In MRD-negative deferred adjuvant therapy group, patients won't get the standard CAPEOX adjuvant therapy at first. When MRD negative status turns to positive status, the 3-month CAPEOX therapy will be arranged.
OTHER	mFOLFOXIRI intensive adjuvant therapy	In the MRD+ intensive standard therapy group, which represents a high risk of recurrence, patients will receive 3-month mFOLFOXIRI intensive therapy, instead of the CAPEOX standard adjuvant therapy.

Timeline

• Start date: 2023-07-26
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2024-01-12
• Last updated: 2024-01-12

Locations

1 site across 1 country: China