ctDNA-based MRD Assessment in Local Advanced Esophageal Carcinoma

Fudan University

Status: Enrolling

Conditions: Esophageal Squamous Cell Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT05426850

ESO-Shanghai16

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-75 years old.
2. ECOG 0-1.
3. Esophageal squamous cell carcinoma confirmed by pathology.
4. No radiotherapy, chemotherapy, or other treatments prior to enrollment.
5. Locally advanced esophageal squamous cell carcinoma (II-IVa, IVB with supraclavicular lymph node metastasis).
6. No severe abnormal hematopoietic, cardiac, pulmonary, renal, hepatic function, or immunodeficiency.
7. Informed consent signed.

Exclusion criteria

1. Less than 50.4Gy/28fx of radiotherapy dose.
2. Without Concurrent chemotherapy.
3. Pregnant or breastfeeding women or fertile patients who refused to use contraceptives.

Trial design

100 participants in 2 patient groups

ctDNA(+) Cohort

Description:

ctDNA(+) Cohort in pretreatment and posttreatment plasma samples was defined by accessing the presence of one or more mutations identified in match tumor samples.

ctDNA(-) Cohort

Description:

ctDNA(-) Cohort in pretreatment and posttreatment plasma samples was defined by the absence of one or more mutations identified in match tumor samples.