A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •No prior radiotherapy, chemotherapy, immunotherapy, or biotherapy for esophageal cancer;
- •ECOG performance status of 0-1;
- •Laboratory test values within the following limits before the first dose of the investigational drug:
- •Hematology: WBC ≥3.0×10⁹/L; ANC ≥1.5×10⁹/L; PLT ≥70×10⁹/L; HGB ≥9.0 g/dL;
- •Liver function: AST ≤2.5×ULN; ALT ≤2.5×ULN;
- •Renal function: Cr ≤1.5×ULN or CrCl ≥40 mL/min;
- •Coagulation: INR ≤1.5, APTT ≤1.5×ULN;
- •Other: Lipase ≤1.5×ULN, unless clinically/radiographically insignificant if lipase >1.5×ULN.
排除标准
- •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);
- •History of gastrointestinal bleeding within the past 6 months, or coagulopathy at enrollment, or current thrombolytic or anticoagulant therapy indicating a high risk of bleeding;
- •Severe cardiovascular or cerebrovascular diseases;
- •History of interstitial lung disease or active pneumonia/tuberculosis;
- •Severe allergic reactions to paclitaxel/cisplatin or any monoclonal antibody;
- •Any other condition deemed inappropriate for participation in this study as judged by the investigator.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: one year
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.
次要结局
未报告次要终点
研究者
Zhifeng Tian,MD
professor
The Central Hospital of Lishui City