ctDNA-based MRD Assessment in Local Advanced Esophageal Carcinoma

Fudan University100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Esophageal Squamous Cell Carcinoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fudan University Shanghai cancer center

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Relationship between ctDNA status after chemoradiotherapy and relapse.

To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma.

Time frame: ctDNA will be tested within 1 year after chemoradiotherapy

Secondary Outcomes

Changes of ctDNA status.

To dynamically evaluate the ctDNA status at baseline, during treatment and follow-up.

Time frame: 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).

To compare OS in ctDNA(+) patients and ctDNA(-) patients.

Time frame: through study completion, an average of 2 years.

Relapse-free survival (RFS) and progression-free survival (PFS).

To compare RFS and PFS in ctDNA(+) patients and ctDNA(-) patients.

Time frame: through study completion, an average of 2 years.

Relationships between radiomics features, ctDNA status and relapse.

To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma compared to traditional radiographic methods.

Time frame: through study completion, an average of 2 years.

Data from ClinicalTrials.gov

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