Based on ctDNA-MRD Guided Adjuvant Treatment Escalation After Definitive Chemoradiotherapy for Un… (NCT07371247) | Clinical Trial Compass
By InvitationEarly Phase 1
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
China65 participantsStarted 2025-12-20
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. No prior systemic therapy administered for the disease, and planned to receive definitive chemoradiotherapy (dCRT).
✓. Having undergone 1021-gene large panel testing on tissue samples.
✓. Aged 18-80 years old.
✓. Expected overall survival ≥ 6 months.
✓. ECOG performance status 0-1.
✓. Normal blood biochemical parameters, with normal liver and kidney function.
✓. Able to understand the study protocol, voluntarily participate in the study, and sign the informed consent form.
Exclusion criteria
What they're measuring
1
PFS
Timeframe: 1 year after enrollment
Trial details
NCT IDNCT07371247
SponsorThe First Affiliated Hospital with Nanjing Medical University