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 type | Observational |
|---|---|
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | August 26, 2024 |
| Main results expected | December 30, 2027 |
| Study ends | June 1, 2028 |
| Registry record updated | August 29, 2024 |
| Trial ID | NCT06561178 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
- 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy
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Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer
This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.
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Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC
This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.
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SKB500 combinations for esophageal squamous cell carcinoma
This study tests SKB500 combined with other drugs to see if it is safe and shows early signs of activity in adults with unresectable or metastatic esophageal squamous cell carcinoma who have limited prior treatment.
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Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
This study tests whether adding cardonilizumab to preoperative chemotherapy (versus chemoradiotherapy) helps patients with locally advanced ESCC have a better chance at complete tumor removal and longer survival.
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Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma
In people with locally advanced ESCC who respond to neoadjuvant immunochemotherapy, this study tests whether organ preservation with treatment other than surgery can be as effective as radical esophagectomy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.