A Phase II and III, Randomized, Multicenter Clinical Study: Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
The goal of this clinical trial is to explore the therapeutic efficacy of immune checkpoint inhibitors combined with radical radiotherapy in elderly patients with esophageal cancer.
详细描述
Older patients with esophageal cancer are universally intolerant to chemotherapy.
This study is performed to explore a non-chemotherapy strategy for elderly esophageal cancer patients.
Participants will be treated with Toripalimab monoclonal antibody maintenance versus S-1 combined with radiotherapy, intended to explore the efficacy and safety of non-chemotherapy strategy for elderly esophageal cancer patients.
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
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Carcinoma of the esophagus confirmed histologically or cytologically. Lesions that can be measured according to the RECIST standard. AJCC/UICC Staging of Esophageal Carcinoma (Sixth Edition) Clinical Staging Ⅱa to Ⅲ.
- •Age ≥ 70 years ≤ 85 years old. The ECOG physical state score is 0 to
- •No esophageal perforation, active esophageal bleeding, or significant invasion of trachea or thoracic aorta.
- •Patients with not previously received chest radiation and speech therapy, immunotherapy, or biological therapy.
- •Hemoglobin ≥ 100g/L, platelets ≥ 100 * 10^9/L, absolute neutrophil count ≥ 1.5 * 10^9/L。 Serum creatinine ≤ 1.25 times UNL or creatinine clearance ≥ 60 mL/min. Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, and alkaline phosphatase ≤ 5 times UNL.
- •No history of interstitial pneumonia or previous interstitial pneumonia. FEV1>0.8L。
- •The patient signs a formal informed consent form.
排除标准
- •Patients with chest radiation, chemotherapy, or surgical resection of esophageal cancer before the start of this trial Patients with multifocal esophageal cancer, and the lower boundary of the primary lesion of the esophagus is less than 3cm from the esophageal gastric junction.
- •Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a previous history of interstitial pneumonia.
- •Patients with obvious esophageal ulcer, moderate or above pain in chest and back, and symptoms of esophageal perforation.
- •Patients who cannot understand or may not comply with the test requirements. Patients with other malignant lesions, except for curable skin cancer (non melanoma), cervical carcinoma in situ or malignant disease that has been cured for ≥ 5 years.
- •Researchers believe that some obvious diseases should be excluded from this study.
研究组 & 干预措施
Toripalimab & Radiotherapy
Toripalimab, 240mg/d, radiotherapy D7, D28; Thoracic radiotherapy, 54Gy/25F, IMRT; Maintenance Toripalimab therapy after completed radiotherapy, 240mg/Q3W, until progression or 1 years or intolerant
干预措施: Toripalimab (Drug)
Toripalimab & Radiotherapy
Toripalimab, 240mg/d, radiotherapy D7, D28; Thoracic radiotherapy, 54Gy/25F, IMRT; Maintenance Toripalimab therapy after completed radiotherapy, 240mg/Q3W, until progression or 1 years or intolerant
干预措施: IMRT (Radiation)
Chemotherapy & Radiotherapy
Tegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT.
干预措施: Tegafur (Drug)
Chemotherapy & Radiotherapy
Tegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT.
干预措施: IMRT (Radiation)
结局指标
主要结局
Overall survival
时间窗: Time Frame: 2 years
The OS was defined as the duration from the date of of initiation of treatment to the date of death from any cause or censored at the date of the last follow-up.
次要结局
- Progression-Free survival(Time Frame: 2 years)
研究者
Haihua Yang
Head of Department of Radiation Oncology
Taizhou Hospital