NCT05426850RecruitingNot Applicable
Circulating Tumor DNA-based Minimal Residual Disease (MRD) Assessment in Local Advanced Esophageal Squamous Cell Carcinoma Treated by Definitive Concurrent Chemoradiotherapy
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Fudan University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Relationship between ctDNA status after chemoradiotherapy and relapse.
Study Overview
Brief Summary
To analyze the relationship between the dynamic changes of circulating tumor DNA (ctDNA) and tumor relapse of esophageal squamous cell carcinoma treated by concurrent chemoradiotherapy.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-75 years old.
- •Esophageal squamous cell carcinoma confirmed by pathology.
- •No radiotherapy, chemotherapy, or other treatments prior to enrollment.
- •Locally advanced esophageal squamous cell carcinoma (II-IVa, IVB with supraclavicular lymph node metastasis).
- •No severe abnormal hematopoietic, cardiac, pulmonary, renal, hepatic function, or immunodeficiency.
- •Informed consent signed.
Exclusion Criteria
- •Less than 50.4Gy/28fx of radiotherapy dose.
- •Without Concurrent chemotherapy.
- •Pregnant or breastfeeding women or fertile patients who refused to use contraceptives.
Outcomes
Primary Outcomes
Relationship between ctDNA status after chemoradiotherapy and relapse.
Time Frame: ctDNA will be tested within 1 year after chemoradiotherapy
To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma.
Secondary Outcomes
- Relapse-free survival (RFS) and progression-free survival (PFS).(through study completion, an average of 2 years.)
- Changes of ctDNA status.(before and at the end of radiotherapy (+1 week); at the end of consolidation chemotherapy (+1 week); at 2 weeks, 1 month, 3 months, 6 months, 9 months, 1 year after dCCRT.)
- Overall survival (OS).(through study completion, an average of 2 years.)
- Relationships between radiomics features, ctDNA status and relapse.(through study completion, an average of 2 years.)
Investigators
Kuai Le Zhao, MD
Professor
Fudan University
Study Sites (1)
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