NCT07371247Enrolling 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
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 20 Dec 2025
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07371247
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 65
- From 20 Dec 2025 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
- Good compliance, able to cooperate with specimen collection at all designated time points and provide relevant clinical data.
- Exclusion Criteria
- Have participated in other clinical trials within 3 months prior to enrollment.
- Have a history of other malignant tumors within 3 years prior to the diagnosis of esophageal cancer.
- Have a history of severe mental illness.
- Patients who are unable to understand the study protocol and thus cannot cooperate, or who refuse to sign the informed consent form.
- Have contraindications to chemoradiotherapy.
- Have a history of autoimmune diseases.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.