ctDNA, Esophageal Cancer, MRD
Conditions
Brief 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.
Interventions
DRUGStep-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.
DRUGStandard 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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria 1. 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. 2. No prior systemic therapy administered for the disease, and planned to receive definitive chemoradiotherapy (dCRT). 3. Having undergone 1021-gene large panel testing on tissue samples. 4. Aged 18-80 years old. 5. Expected overall survival ≥ 6 months. 6. ECOG performance status 0-1. 7. Normal blood biochemical parameters, with normal liver and kidney function. 8. Able to understand the study protocol, voluntarily participate in the study, and sign the informed consent form. 9. Good compliance, able to cooperate with specimen collection at all designated time points and provide relevant clinical data. *
Exclusion criteria
1. Have participated in other clinical trials within 3 months prior to enrollment. 2. Have a history of other malignant tumors within 3 years prior to the diagnosis of esophageal cancer. 3. Have a history of severe mental illness. 4. Patients who are unable to understand the study protocol and thus cannot cooperate, or who refuse to sign the informed consent form. 5. Have contraindications to chemoradiotherapy. 6. Have a history of autoimmune diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | 1 year after enrollment |
Countries
China
Outcome results
None listed