JPRN-jRCTs031230219招募中3 期
JCOG2206: A randomized controlled phase III study comparing surgery alone versus adjuvant nivolumab versus adjuvant S-1 for locally advanced esophageal squamous cell carcinoma with no pathological complete response after neoadjuvant chemotherapy followed by curative esophagectomy - SUNRISE
KITAGAWA Yuko0 个研究点目标入组 450 人开始时间: 2023年7月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •(1) Histologically proven esophageal squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
- •(2) All lesions including primary tumor located in the thoracic esophagus.
- •(3) Multiple tumors are eligible. Secondary lesion in the cervical esophagus which is indicated for endoscopic resection (EMR/ESD) is eligible.
- •(4) Clinical stage I (except for T1N0), II, III, IVA (except for T4), IVB (only supraclavicular lymph node metastasis except for T4) based on the cervical to abdominal contrast-enhanced CT (UICC-TNM 8th edition). After staging, patients received neoadjuvant chemotherapy (less than 3 courses of DCF or 2 courses of CF).
- •(5) Right-thoracoabdominal esophagectomy with D2 or higher lymph node dissection including minimally invasive procedure (thoracoscopy, laparoscopy, and robot-assisted) was accomplished within 21 to 90 days after neoajuvant chemotherapy.
- •(6) R0 resection was performed.
- •(7) Diagnosed with ypstage T0-4aN1-3M0, T1-4aN0M0, T0-4aNanyM1 (only supraclavicular lymph node metastasis) by surgical specimens (UICC-TNM 8th edition).
- •(8) Age between 18 and 80 at registration.
- •(9) Performance Status (ECOG) 0 or 1.
- •(10) Within 28 to 70 days after esophagectomy.
- •(11) No prior endocrine therapy, chemotherapy, molecular targeted therapy, and immunotherapy against any other malignancies within 5 years, and no prior cervical and thoracic radiotherapy for other malignancies. Hormone therapy for breast cancer or prostate cancer is eligible.
- •(12) No active autoimmune disease and no history of chronic or recurrent autoimmune disease.
- •(13) Sufficient organ function
- •i) Neutrophil >= 1,200/mm3
- •ii) Hb >= 8.0 g/dL
- •iii) Platelet >= 75,000/mm3
- •iv) T.Bil <= 2.0 mg/dL
- •v) AST <= 100 U/L
- •vi) ALT <= 100 U/L
- •vii) SpO2 >= 95%(room air)
- •viii) CCr >= 50 mL/min
- •(14) Written informed consent from patient
排除标准
- •(1) Synchronous or metachronous (within 5 years) malignancies.
- •(2) Infectious disease requiring systemic treatment.
- •(3) Body temperature of 38 degrees Celsius or higher.
- •(4) Female during pregnancy, within 28 days of postparturition, or during lactation. Males with partners planning conception shortly.
- •(5) Psychological disorder difficult to participate in this clinical study.
- •(6) Receiving continuous systemic corticosteroid with a prednisolone equivalent greater than 10 mg/day, immunosuppressant treatment or immunoglobulin.
- •(7) Under treatment with flucytosine, phenytoin, or warfarin.
- •(8) Positive for HBs antigen or HIV antigen.
- •(9) Uncontrolled diabetes mellitus.
- •(10) Uncontrolled arterial hypertension.
- •(11) History of unstable angina pectoris within 3 weeks or myocardial infarction within 6 months before registration.
- •(12) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
- •(13) Severe emphysema, interstitial pneumonia, or pulmonary fibrosis based on chest CT.
研究者
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