An Early Phase 1 interventional study of Step-up therapy and Standard treatment Routine treatment in Esophageal Cancer, MRD and ctDNA, sponsored by The First Affiliated Hospital with Nanjing Medical University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Early Phase 1, Interventional, and Treatment
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.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 65 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically confirmed locally advanced esophageal squamous cell carcinoma (ESCC), with clinical stage Ⅱ-Ⅳ unresectable disease (including unresectable cases, patients with surgical contraindications, or those who refuse surgery). According to the 8th edition AJCC staging system, the pretreatment clinical stage is defined as: cT1N2-3M0, cT2-4bN0-3M0; M1 disease is limited to non-regional lymph node metastases, excluding distant organ metastases.
Have participated in other clinical trials within 3 months prior to enrollment.
Assessed as MRD-positive based on ctDNA testing
Drug: Step-up therapy
Assessed as MRD-negative based on ctDNA testing
Drug: Standard treatment Routine treatment
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.
Patients receive 2 cycles of consolidative intravenous chemotherapy and then proceed to routine follow-up. MRD testing is repeated after the completion of chemotherapy.
PFS
Time frame: 1 year after enrollment
Plan to share: No
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The First Affiliated Hospital with Nanjing Medical University