An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer vs Cross Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- 3-year overall survival rate
研究概览
简要总结
Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to receive neoadjuvant chemo-radiotherapy combined with immunotherapy post organ preservation strategy (experimental group) or neoadjuvant chemo-radiotherapy followed by surgery (control group).
The 3-year overall survival rate is the primary outcome.
详细描述
The investigators will conduct the open, multicenter, prospective, randomized controlled clinical study(PALACE3). Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to either receive neoadjuvant synchronous radiotherapy and chemotherapy combined with immunotherapy followed by organ preservation strategy (experimental group, Arm1) or neoadjuvant concurrent radiotherapy and chemotherapy followed by radical surgery (control group,Arm 2). Collect relevant data on preoperative treatment, re examination after neoadjuvant therapy, perioperative and long-term follow-up of patients, and evaluate the clinical treatment effects (cCR rate), surgical pathological results (pCR rate, R0 resection rate, tumor regression grade, lymph node positivity rate), neoadjuvant therapy and perioperative complications, long-term oncological effects (total survival, disease-free survival), and quality of life of the two treatment plans through statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomize patients who meet the inclusion criteria Grouping, randomly assigned to the experimental group in a 1:1 ratio (organ preservation strategy after neoadjuvant chemotherapy combined with immunotherapy) And the control group (limited time for esophageal cancer radical surgery after neoadjuvant radiotherapy and chemotherapy)
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
- •A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
- •Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Patients approve and sign the informed consent
排除标准
- •Patients with active autoimmune disease or history of autoimmune disease.
- •Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
- •Subjects with a history of symptomatic interstitial lung disease.
- •History of allergy to study drug components.
- •Women must not be pregnant or breast-feeding.
- •Men with female partners (WOCBP) that are not willing to use contraception.
- •Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy.
- •medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events
结局指标
主要结局
3-year overall survival rate
时间窗: From date of randomization until the date of death from any cause，up to 5 years
The proportion of patients who survived within 3 years from randomization
次要结局
未报告次要终点