ctDNA-based MRD Assessment in Local Advanced Esophageal Carcinoma

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma

• Registration Number: NCT05426850
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2022-05-24
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-16
• Last Update Submitted: 2022-06-16
• Study First Posted: 2022-06-22
• Last Update Posted: 2022-06-22
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between ctDNA status after chemoradiotherapy and relapse.	ctDNA will be tested within 1 year after chemoradiotherapy	To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma.

Secondary Outcome Measures

Name	Time	Method
Relapse-free survival (RFS) and progression-free survival (PFS).	through study completion, an average of 2 years.	To compare RFS and PFS in ctDNA(+) patients and ctDNA(-) patients.
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.	To dynamically evaluate the ctDNA status at baseline, during treatment and follow-up.
Overall survival (OS).	through study completion, an average of 2 years.	To compare OS in ctDNA(+) patients and ctDNA(-) patients.
Relationships between radiomics features, ctDNA status and relapse.	through study completion, an average of 2 years.	To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma compared to traditional radiographic methods.

Trial Locations

Locations (1)

Fudan University Shanghai cancer center; 🇨🇳 Shanghai, Shanghai, China