A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall Survival Rate
研究概览
简要总结
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Aged ≥ 18 years at the time of screening.
- •Histologically confirmed squamous cell carcinoma;
- •Locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery;
- •Eastern Cooperative Oncology Group (ECOG) performance status:0-2;
- •Able to eat a semi-liquid diet;
- •Less than 20% weight loss within 6 months;
- •Adequate hepatic function, renal function, hematologic function and coagulation function;
- •Documented informed consent.
排除标准
- •Distant metastasis;
- •Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer;
- •Prior thoracic irradiation, chemotherapy, or lobectomy
- •Known diseases or conditions that are contraindicated for radiotherapy or surgery;
- •Allergy to the research medications;
- •Pregnant women or women preparing for pregnancy;
- •Diagnosis of autoimmune disease or history of chronic autoimmune disease
- •Absence of informed consent because of psychological, family, social and other factors;
- •Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).
研究组 & 干预措施
experimental arm
Induction Therapy: Two cycles of induction chemotherapy (nab-paclitaxel 200 mg/m², day 1; carboplatin AUC 5, day 1) combined with a PD-1 inhibitor (200 mg, day 1) every 3 weeks.
Concurrent Therapy: Followed by concurrent chemoradiotherapy (CCRT).
Maintenance Therapy: Patients without progressive disease (PD) will receive maintenance immunotherapy with a PD-1 inhibitor (200 mg every 3 weeks) for up to 1 year.
干预措施: chemotherapy combined with PD-1 inhibitors (Drug)
结局指标
主要结局
Overall Survival Rate
时间窗: 2 years after last patient enrolled
Overall survival rate is defined as the percentage of participants who are alive up to 2 years from enrollment
次要结局
- Treatment related complications(During the procedure)
- progression-free Survival (PFS)(2 years after last patient enrolled)
研究者
Jun Liu
associate professor
Shanghai Chest Hospital