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Trial Title:
Individualized Tumor-Informed CtDNA Analysis for Monitoring Postoperative Recurrence in ESCC (NEOCRTEC2401)
NCT ID:
NCT06561178
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Recurrence
Conditions: Keywords:
ctDNA
recurrence detection
esophageal squamous cell carcinoma
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients with esophageal squamous cell carcinoma who have not achieved pCR following
neoadjuvant chemoradiotherapy and surgery.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 26, 2024
Completion date:
June 1, 2028
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06561178
