NCT06561178 Individualized Tumor-Informed CtDNA Analysis for Monitoring Postoperative Recurrence in ESCC (NEOCRTEC2401)
| NCT ID | NCT06561178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-Sen University Cancer Center |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-08-26 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-08-26 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Hong Yang, M.D.;Ph.D.
PRINCIPAL INVESTIGATOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT06561178 clinical trial?
This trial is open to participants of all sexes, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06561178 currently recruiting?
Yes, NCT06561178 is actively recruiting participants. Contact the research team at yanghong@sysucc.org.cn for enrollment information.
Where is the NCT06561178 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06561178 clinical trial?
NCT06561178 is sponsored by Sun Yat-Sen University Cancer Center. The principal investigator is Hong Yang, M.D.;Ph.D. at Sun Yat-Sen University Cancer Center. The trial plans to enroll 50 participants.