Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06792786

A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring

Led by The Central Hospital of Lishui City · Updated on 2026-03-23

30

Participants Needed

2

Research Sites

159 weeks

Total Duration

On this page

Sponsors

T

The Central Hospital of Lishui City

Lead Sponsor

A

Affiliated Hospital of Jiaxing University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Esophageal squamous cell carcinoma (ESCC) continues to exhibit high incidence and mortality rates in China, with the majority of patients diagnosed at middle to advanced stages. Concurrent chemoradiotherapy (CCRT) is the standard treatment for unresectable locally advanced ESCC. The 5-year survival rate for advanced esophageal cancer remains below 20%. Immunotherapy has demonstrated definitive efficacy and a favorable toxicity profile in advanced ESCC, and preliminary results of its combination with radiotherapy have been reported. Induction immunochemotherapy followed by concurrent chemoradiotherapy represents a feasible combined treatment strategy. However, optimal biomarkers to identify patients who would benefit from this approach are still lacking. Circulating tumor DNA (ctDNA) status can accurately guide treatment implementation and predict tumor progression. Studies have shown that ctDNA changes precede imaging evidence of recurrence or metastasis, and ctDNA detection can sensitively predict tumor progression and prognosis. Therefore, it is necessary to dynamically monitor ctDNA changes throughout the course of induction immunochemotherapy followed by radical concurrent chemoradiotherapy in esophageal cancer and explore its correlation with prognosis.

CONDITIONS

Official Title

A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before study procedures
  • Aged 18 to 75 years
  • Histologically or cytologically confirmed esophageal squamous cell carcinoma
  • Clinical stage II-IVa, deemed inoperable by a surgeon or declined surgery
  • No prior radiotherapy, chemotherapy, immunotherapy, or biotherapy for esophageal cancer
  • ECOG performance status of 0-1
  • Laboratory tests before treatment meeting specific blood counts, liver, kidney, coagulation, and lipase levels
Not Eligible

You will not qualify if you...

  • Insufficient tissue or blood samples before treatment as required
  • Refusal to undergo dynamic ctDNA testing
  • Primary esophageal lesion too close to tracheobronchial tree or major blood vessels with high risk of perforation or bleeding
  • History of other malignancies within 5 years except certain treated localized tumors
  • Gastrointestinal bleeding within 6 months, coagulopathy, or current thrombolytic/anticoagulant therapy with high bleeding risk
  • Severe cardiovascular or cerebrovascular diseases
  • History of interstitial lung disease or active pneumonia or tuberculosis
  • Severe allergic reactions to paclitaxel, cisplatin, or monoclonal antibodies
  • Any condition deemed unsuitable for study participation by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China, 321000

Actively Recruiting

2

The central Hospital of Lishui City

Lishui, Zhejiang, China, 323000

Actively Recruiting

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Research Team

Z

Zhifeng Tian, MD

CONTACT

S

Shubo Ding, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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