NCT06463834招募中2 期
A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathological complete response
研究概览
简要总结
This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy (docetaxel+cisplatin+5-fluorouracil, DCF) in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma.
详细描述
This study was designed as a single arm, phase II trial. Subjects will receive 3 cycles of Sintilimab combined with DCF as neoadjuvant therapy. The primary endpoint is pathologic complete response(pCR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •≥18 years old and ≤75 years old
- •Esophageal squamous cell carcinoma diagnosed biopsy histopathology
- •The primary tumor is located in the middle of the esophagus and T1b-3N1-3M0 /M1 or T3N0M0 diagnosed by CT/MRI/EUS (AJCC 8th)
- •At least one measurable lesion
- •Eastern cooperative oncology group (ECOG) performance status of 0 to 1
- •With adequate organs function
排除标准
- •Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
- •Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
- •Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy
结局指标
主要结局
Pathological complete response
时间窗: 4 weeks after surgery
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
次要结局
- Major pathological response(4 weeks after surgery)
- Incidence rate of adverse events(3-year)
- Disease-free survival period(3-year)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT06152978Fudan University182
Unknown
2 期
Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Operable Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT05174325The First Affiliated Hospital of Soochow University30
已完成
2 期
Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCCEsophageal Squamous Cell CarcinomaNCT03985046Fudan University75
招募中
2 期
A Study to Evaluate the Efficacy and Safety of Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative Microsatellite Stability (MSS) Advanced or Metastatic Gastric (GC) or Gastroesophageal Junction (GEJ) CancerChemotherapyImmunotherapyGastric CancerNCT05216237Jiuda Zhao31
尚未招募
不适用
Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast CancerHER2-negative Breast CancerNCT05334147The First Affiliated Hospital with Nanjing Medical University315