Clinical trial Recruiting at 1 site Observational

Monitoring postoperative recurrence in esophageal cancer using ctDNA analysis

Official title: Individualized Tumor-Informed Circulating Tumor DNA (ctDNA) Analysis for Monitoring Postoperative Recurrence Following Neoadjuvant Therapy in Esophageal Squamous Cell Carcinoma (NEOCRTEC2401)

Run by Sun Yat-sen University · NCT06561178 · Data updated 2026-11-12

This study is testing if tracking changes in tumor DNA after surgery can help predict if esophageal cancer will come back in patients who didn't fully respond to earlier treatment.

Quick facts

Study typeObservational
SexAll
Enrollment50 (estimated)
SponsorSun Yat-sen University
Academic / other
Drugs / interventionsimmunotherapy
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedAugust 26, 2024
Main results expectedDecember 30, 2027
Study endsJune 1, 2028
Registry record updatedAugust 29, 2024
Trial IDNCT06561178 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with operable locally advanced esophageal squamous cell carcinoma who have undergone neoadjuvant therapy and have not achieved a complete pathological response.

Probably not a fit

Patients with concurrent malignancies or severe uncontrolled medical conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the relationship between changes in circulating tumor DNA (ctDNA) after surgery and the risk of recurrence in patients with esophageal squamous cell carcinoma who did not achieve a complete pathological response following neoadjuvant therapy. Participants will undergo ctDNA detection to assess molecular residual disease, which may help inform postoperative treatment decisions. The study seeks to establish whether dynamic ctDNA changes can serve as a reliable indicator of tumor recurrence.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized postoperative treatment strategies for patients with esophageal cancer.

How similar studies have gone: Similar studies utilizing ctDNA for monitoring cancer recurrence have shown promising results, indicating potential for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Operable locally advanced esophageal squamous cell carcinoma;
2. Have received neoadjuvant chemoradiotherapy ± immunotherapy and have not achieved pCR after R0 resection;
3. Can tolerate postoperative adjuvant immunotherapy;
4. Sufficient baseline tumor tissue and blood samples available for NGS testing;
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
6. Consents to and is capable of complying with the scheduled study visits, treatment plans, laboratory tests, and other study procedures
7. Expected postoperative survival time of ≥ 6 months.

Exclusion Criteria:

1. Concurrent other malignant tumors;
2. Lack of a detailed histopathological diagnostic report for determining the nature of the lesion;
3. Severe and/or poorly controlled medical conditions that, in the investigator's judgment, could affect participation or interfere with study results;
4. Any social/psychological issues that, in the investigator's judgment, make the patient unsuitable for participation;
5. Unable to undergo long-term, regular postoperative follow-up at the current medical institution;
6. Unwilling or unable to comply with the study protocol.

Where it's running

  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.