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.
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;
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);
Single group
Induction Immunochemotherapy
Diagnostic testInduction Immunochemotherapy:Toripalimab 240 mg (immunotherapy) combined with paclitaxel (135 mg/m²) and cisplatin (75 mg/m²) chemotherapy, administered every 3 weeks for 2 cycles. Other Names: - Radiotherapy: 95% PTV 50-50.4 Gy/25-28 fractions, 1.8-2 Gy/fraction; 5 days per week. - Chemotherapy: Weekly paclitaxel (50 mg/m²) combined with cisplatin (25 mg/m²) for 5 cycles. ctDNA Analysis:Initial tissue and blood ctDNA testing prior to treatment (T0) is based on next-generation sequencing (NGS) technology, utilizing tumor-informed assays. Blood ctDNA samples will be collected before chemoradiotherapy, after 20 fractions of radiotherapy, and every 3 months following completion of chemoradiotherapy.
Progression-free survival (PFS)
We aim to evaluate the progression-free survival (PFS) of patients with unresectable esophageal squamous cell carcinoma who accept concurrent chemoradiotherapy and received sequential treatment with Triptolide injection after radiotherapy.
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The Central Hospital of Lishui City
Lead sponsor
Affiliated Hospital of Jiaxing University
Collaborator
People's Hospital of Quzhou
Collaborator
Jinhua Central Hospital
Collaborator
