Status:
RECRUITING
Individualized Tumor-Informed CtDNA Analysis for Monitoring Postoperative Recurrence in ESCC (NEOCRTEC2401)
Lead Sponsor:
Sun Yat-sen University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
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 det...
Eligibility Criteria
Inclusion
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Consents to and is capable of complying with the scheduled study visits, treatment plans, laboratory tests, and other study procedures
- Expected postoperative survival time of ≥ 6 months.
Exclusion
- 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;
- Unable to undergo long-term, regular postoperative follow-up at the current medical institution;
- Unwilling or unable to comply with the study protocol.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06561178
Start Date
August 26 2024
End Date
June 1 2028
Last Update
August 29 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060