Monitoring postoperative recurrence in esophageal cancer using ctDNA analysis
Individualized Tumor-Informed Circulating Tumor DNA (ctDNA) Analysis for Monitoring Postoperative Recurrence Following Neoadjuvant Therapy in Esophageal Squamous Cell Carcinoma (NEOCRTEC2401)
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 type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06561178 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with concurrent malignancies or severe uncontrolled medical conditions may not benefit from this study.
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 performed: Similar studies utilizing ctDNA for monitoring cancer recurrence have shown promising results, indicating potential for this approach.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hong Yang, M.D.;Ph.D. — Sun Yat-Sen University Cancer Center
- Study coordinator: Hong Yang, MD
- Email: yanghong@sysucc.org.cn
- Phone: 86-020-87343932
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.