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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Central Hospital of Lishui City

About this trial

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.

Eligibility criteria

Qualifiers

All subjects must sign an informed consent form before initiating any study-related procedures;

All patients must be aged ≥18 years and ≤75 years;

Histologically or cytologically confirmed esophageal cancer (squamous cell carcinoma);

Clinical stage II-IVa, assessed by a surgeon as inoperable, or patient refusal of surgery;

Disqualifiers

Insufficient tissue/blood sample available before treatment as required for the study;

Patient refusal to undergo dynamic ctDNA testing;

The primary esophageal lesion is in close proximity to the tracheobronchial tree or major blood vessels, with an investigator-assessed high risk of perforation or major hemorrhage;

History of malignancies other than esophageal carcinoma within the past 5 years (except for curatively treated localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or localized prostate cancer);

Trial design

Treatments tested in this trial

  • Induction Immunochemotherapy

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

The Central Hospital of Lishui City

Lead sponsor

Affiliated Hospital of Jiaxing University

Collaborator

People's Hospital of Quzhou

Collaborator

Jinhua Central Hospital

Collaborator