NCT07371247

Based on ctDNA-MRD Guided Adjuvant Treatment Escalation After Definitive Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Study on Safety and Efficacy

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Numerous studies have confirmed that ctDNA-MRD detection technology based on peripheral blood can identify minimal residual disease (MRD) following surgery and other curative treatments, indicating a higher risk of recurrence. Multiple exploratory studies in esophageal cancer have demonstrated that patients who are ctDNA-MRD positive after definitive chemoradiotherapy (dCRT) exhibit poorer progression-free survival (PFS) and a higher risk of recurrence. Furthermore, the recent NEXUS-1 translational study confirmed that 66.7% of unresectable patients achieved the goal of conversion surgery after receiving definitive chemoradiotherapy combined with immunotherapy. Notably, patients who were ctDNA-MRD positive after chemoradiotherapy had a significantly worse prognosis. These findings suggest that ctDNA-MRD status after chemoradiotherapy has prognostic stratification value and that consolidative immunotherapy is effective. Based on these previous discoveries, this study aims to investigate the safety and efficacy of an escalated treatment strategy involving immunotherapy combined with chemotherapy for high-risk populations after definitive chemoradiotherapy for esophageal cancer, guided by personalized MRD detection results.

Conditions

• Esophageal Cancer
• MRD
• ctDNA

Interventions

Type	Name	Description
DRUG	Step-up therapy	Patients receive step-up therapy, consisting of 4 cycles of immunotherapy combined with intravenous chemotherapy, followed by immunotherapy plus oral chemotherapy for 6 months. MRD testing is repeated after the completion of immunotherapy combined with intravenous chemotherapy.
DRUG	Standard treatment Routine treatment	Patients receive 2 cycles of consolidative intravenous chemotherapy and then proceed to routine follow-up. MRD testing is repeated after the completion of chemotherapy.

Timeline

• Start date: 2025-12-20
• Primary completion: 2027-10-31
• Completion: 2027-11-30
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: China