Clinical Design and Objectives

Ruijin Hospital, affiliated with the School of Medicine at Shanghai Jiao Tong University, has initiated the ADX-DRIVER-CRC study, enrolling 392 patients with stages I–III colorectal cancer. NCT07795528 is a multicenter, prospective observational cohort launched on August 14, 2026, and is not a Phase I–III interventional clinical trial but a non-interventional study to evaluate post-marketing diagnostic strategies. The study will follow patients aged 18–75 who have undergone curative resection and carry at least one oncogenic mutation in KRAS, NRAS, BRAF, or PIK3CA for three years, with primary completion and study end dates scheduled for December 31, 2030.

Testing Methods and Outcome Measures

Researchers will collect plasma at defined time points post-surgery and measure ctDNA-based molecular residual disease (MRD) using a standardized next-generation sequencing (NGS) panel covering 10 genes. The primary outcome measure is the association between post-surgical MRD positivity and recurrence-free survival (RFS), with secondary analyses including overall survival (OS), lead time for recurrence detection compared to imaging, and MRD changes during adjuvant chemotherapy. The study aims to compare detection rates and prognostic performance by mutation type to refine adjuvant therapy decisions based on molecular risk rather than staging alone.

Treatment Context and Competitive Landscape

The trial protocol does not assign specific drugs or target molecules, and patients will receive standard follow-up and clinically determined adjuvant therapies. The standard treatment for high-risk stage II and III colon cancer after resection is oxaliplatin (a DNA crosslinking agent)-based FOLFOX or CAPOX. Competing MRD platforms include Natera (NTRA)'s Signatera, Guardant Health (GH)'s Guardant Reveal, and Exact Sciences (EXAS)'s Oncodetect. While Signatera is a patient-specific tumor-informed test and Guardant Reveal uses blood-only genomic and methylation analysis, the 10-gene panel in this study tracks predefined driver mutations to standardize testing and improve cost efficiency.

Market Potential and Clinical Significance

The global colorectal cancer liquid biopsy market is estimated at USD 1.8 billion in 2025, with the overall colorectal cancer diagnostics market reaching USD 9.5 billion in the same year. MRD testing adoption is a key driver for repeat testing revenue. In a stage III colon cancer analysis using Guardant Reveal, the 3-year recurrence rate was 62.6% in the ctDNA-positive group and 15.4% in the negative group, demonstrating MRD's strong risk-stratification capability. NCT07795528 is an observational study to validate the analytic and prognostic utility of 10-gene ctDNA-MRD in the Chinese patient population, not a drug approval trial or regulatory submission. Positive results could provide evidence to differentiate between intensified and de-escalated anti-cancer therapy and create partnership opportunities for local diagnostic initiatives.