Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma: a Multi-Centre, Open-Label, Randomized, Controlled, Clinical Trial (HCHTOG2203)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Disease-free Survival (DFS)
研究概览
简要总结
No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven squamous cell carcinoma.
- •Tumours are located in the thoracic oesophagus.
- •Age is between 18 years and 70 years.
- •ECOG performance status of 0 or
- •Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease is found after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and pathologically proven T1-2N+M0 after upfront surgery.
- •No metastatic cervical lymph nodes.
- •R0 resection is achieved by the minimally invasive esophagectomy (MIE) or open McKeown approach with total two-field lymph nodes dissection or three-field lymph nodes dissection.
- •No prior therapy was administered against other cancers.
- •Adequate bone marrow function: white blood cell count ≥ 4×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/l; platelets ≥ 100×109/L; haemoglobin ≥ 9 g/dl.
- •Adequate liver function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 × ULN (ULN as per institutional standard).
- •Adequate renal function: glomerular filtration rate ≥ 60 ml/min calculated using the Cockcroft-Gault formula.
- •Normal thyroid function.
- •Written consent is obtained.
排除标准
- •Patients receive neoadjuvant chemoradiation therapy.
- •Patients with pathological complete response (pCR).
- •No. of lymph node dissection <
- •Patients with clinical stages T1-2N+M0 and receive upfront surgery.
- •Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy.
- •Patients requiring systemic steroid medication.
- •Patients with severe postoperative complications and not suitable for adjuvant therapy.
- •Synchronous or metachronous (within 5 years) double cancers.
- •Patients ever received immunotherapy.
- •Active infection requiring systemic therapy.
- •Patients ever received organ transplant or allogenic haemopoietic stem cell transplantation.
- •Patients with human immunodeficiency virus (HIV) infection.
- •Psychiatric disease.
- •Pregnant or lactating women or women of childbearing potential.
- •Hypersensitivity for Sintilimab.
研究组 & 干预措施
Adjuvant Arm
Patients in arm A receive 17 cycles of Sintilimab within 4 to 12 weeks after esophagectomy for ESCC. Sintilimab was administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks.
干预措施: Sintilimab (Drug)
结局指标
主要结局
Disease-free Survival (DFS)
时间窗: DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death , assessed up to 36 months
DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death.
次要结局
未报告次要终点
研究者
Haibo Sun
Vice Chief, Department of Thoracic Surgery
Henan Cancer Hospital