Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
研究概览
简要总结
Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone.
The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.
详细描述
Patients with oligometastatic squamous cell carcinoma were enrolled and 2:1 randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy (radiotherapy, surgery, radiofrequency/microwave ablation, etc.) or PD-1 inhibitor +/- chemotherapy alone. Different local therapy techniques are allowed to be used on different lesions in the same patient.All suspected malignant lesion should be included in local treatment planning in principle.
The primary end point was progression-free survival (PFS). The second end points included overall survival, side effects and local control.
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
- •≥18 years old;
- •Esophageal squamous cell carcinoma
- •ASTRO/ESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm;
- •≥1 pathologically diagnosed metastases
排除标准
- •History of disseminated metastases or ASTRO/ESTRO defined induced oligometastatic disease 2.Esophageal perforation/hemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20>25%
研究组 & 干预措施
PD-1 inhibitor+/- chemotherapy combined with local therapy
Patients randomized to this arm will receive local treatment combined with systemic treatment (immunotherapy or chemo-immunotherapy)
干预措施: PD-1 inhibitor+/- chemotherapy combined with local therapy (Combination Product)
PD-1 inhibitor +/- chemotherapy alone
Patients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy)
干预措施: systemic therapy alone (Drug)
结局指标
主要结局
Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
时间窗: 3-year
The time between the start of the study treatment(day 1) and progression disease(PD)
次要结局
- local control rate(1-year, 3-year)
- overall survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone(3-year)
- treatment related side effect(acute side effects within 3 months, late side effects for 3 months later)
研究者
Kuai Le Zhao, MD
professor
Fudan University