Individualized Tumor-Informed CtDNA Analysis for Monitoring Postoperative Recurrence in ESCC (NEOCRTEC2401)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSun Yat-Sen University Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • molecular residual disease detection

Treatment groups

No treatment groups listed

Sponsors and collaborators

Sun Yat-Sen University Cancer Center

Lead sponsor

Sun Yat-sen University

Sponsor institution