Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Aged 18 years or above
- •Histologically confirmed esophageal squamous cell carcinoma
- •Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification
- •7. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1
- •Life expectancy ≥3 months
- •Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN
排除标准
- •Esophageal perforation or hematemesis
- •Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
- •Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1/PD-L
- •Allergic to any of the ingredients in PD-1 inhibitors for injection.
- •Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
- •Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
- •Active infection or unexplained fever >38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
- •Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
- •According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.
研究组 & 干预措施
TDLN-sparing RT and PD-1 inhibitor maintenance therapy
TDLN-sparing radiotherapy 50.4Gy/28Fx.
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.
干预措施: PD-1 inhibitor (Drug)
TDLN-sparing RT and PD-1 inhibitor maintenance therapy
TDLN-sparing radiotherapy 50.4Gy/28Fx.
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.
干预措施: TDLN-sparing radiotherapy (Radiation)
TDLN-sparing RT and PD-1 inhibitor maintenance therapy
TDLN-sparing radiotherapy 50.4Gy/28Fx.
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.
干预措施: TP regimen (Drug)
TDLN-sparing RT and surveillance
TDLN-sparing radiotherapy 50.4Gy/28Fx.
干预措施: TDLN-sparing radiotherapy (Radiation)
TDLN-sparing RT and surveillance
TDLN-sparing radiotherapy 50.4Gy/28Fx.
干预措施: TP regimen (Drug)
Unlimited RT and PD-1 inhibitor maintenance therapy
Unlimited radiotherapy 50.4Gy/28Fx.
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.
干预措施: PD-1 inhibitor (Drug)
Unlimited RT and PD-1 inhibitor maintenance therapy
Unlimited radiotherapy 50.4Gy/28Fx.
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.
干预措施: Unlimited radiotherapy (Radiation)
Unlimited RT and PD-1 inhibitor maintenance therapy
Unlimited radiotherapy 50.4Gy/28Fx.
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.
干预措施: TP regimen (Drug)
Unlimited RT and surveillance
Unlimited radiotherapy 50.4Gy/28Fx.
干预措施: Unlimited radiotherapy (Radiation)
Unlimited RT and surveillance
Unlimited radiotherapy 50.4Gy/28Fx.
干预措施: TP regimen (Drug)
结局指标
主要结局
PFS
时间窗: 2 years
PFS for all patients with PD-1 inhibitor maintenance therapy vs all patients with surveillance
次要结局
- OS(2 years)
- Adverse events(up to 2 years)
- PFS(2 years)