The goal of this observational study or is to explore the correlation between dynamic changes in postoperative circulating tumor DNA (ctDNA) and recurrence risk using a novel, tumor-informed ctDNA detection technique, thus laying the foundation for further promoting ctDNA detection to guide postoperative adjuvant therapy decisions. This study focuses on patients with esophageal squamous cell carcinoma who did not achieve pCR following neoadjuvant therapy combined with surgical resection. The main question it aims to answer is:
Is there a correlation between postoperative ctDNA changes and tumor recurrence?
Participants will be asked to undergo postoperative ctDNA detection.
Operable locally advanced esophageal squamous cell carcinoma;
Have received neoadjuvant chemoradiotherapy ± immunotherapy and have not achieved pCR after R0 resection;
Can tolerate postoperative adjuvant immunotherapy;
Sufficient baseline tumor tissue and blood samples available for NGS testing;
Concurrent other malignant tumors;
Lack of a detailed histopathological diagnostic report for determining the nature of the lesion;
Severe and/or poorly controlled medical conditions that, in the investigator's judgment, could affect participation or interfere with study results;
Any social/psychological issues that, in the investigator's judgment, make the patient unsuitable for participation;
Patients with esophageal squamous cell carcinoma who have not achieved pCR following neoadjuvant chemoradiotherapy and surgery.
Case-only
Prospective
molecular residual disease detection
Diagnostic testctDNA detection
Correlation between the recurrence of patients and the quantitative measurement of circulating tumor DNA (ctDNA) concentration.
Correlation were evaluated based on the sensitivity and specificity of ctDNA in predicting recurrence.The sensitivity and specificity were determined by evaluating the association between positive ctDNA and tumor recurrence.
Postoperative molecular residual disease (MRD) positive rate
Correlation between ctDNA detection and postoperative adjuvant therapy.
The ctDNA assay was employed to inform postoperative adjuvant therapy, with the objective of determining its potential to enhance patient prognosis.
correlation between patients' prognosis and landmark MRD status
The sensitivity and specificity were determined by evaluating the association between positive landmark MRD status and patients' prognosis.
2-year disease-free survival
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Sun Yat-Sen University Cancer Center
Lead sponsor
Sun Yat-sen University
Sponsor institution
