JPRN-jRCTs041210002招募中2 期
Phase II study of carboplatin, etoposide, and atezolizumab for elderly patients with extensive stage small-cell lung cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
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
- >= 75age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients with small cell lung cancer (SCLC) confirmed histologically or cytologically.
- •2) Patients with extensive stage, postoperative recurrence, or postchemoradiotherapy recurrence
- •3) Previously untreated patients. Any postoperative chemotherapy or chemoradiotherapy given at least 6 months before enrollment in the present study is acceptable.
- •4) Age of 75 years or older at the time of informed consent
- •5) ECOG performance status of 0-2
- •6) The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) meets the following all standard.
- •1. Neutrophil count >= 1500/mm3
- •2. Haemoglobin >= 8.0g/dL
- •3. Platelet count >= 10.0x10000/mm3
- •4. AST <= 100IU/L
- •5. ALT <= 100IU/L
- •6. Total bilirubin <= 1.5mg/dL
- •7. Creatinine <= 1.2mg/dL
- •8. Creatinine clearance >= 50mL/min
- •9. SpO2 >= 90%
- •7) patients have a life expectancy of at least 3 months
- •8) Patients providing the written informed consent.
排除标准
- •1) Symptomatic brain metastasis required for radiation therapy or surgical resection.
- •2) Patients with severe complication, such as cerebrovascular disease, transient ischemic attacks, symptomatic heart failure, uncontrollable angina pectoris,
- •or myocardial infarction within 1 year.
- •3) Patients with active double cancer (synchronous double cancer and asynchronous double cancer within 3 years of progression-free period. However, the lesions correspondent to carcinoma in situ and intramucosal carcinoma curable by topical treatment are excluded)
- •4) Patients treated with palliative radiotherapy within 7 days prior to enrolment
- •5) Patients with active Hepatitis B or C.
- •6) History of interstitial pulmonary disease, drug-induced interstitial pulmonary disease and irradiation pneumonitis required for steroidal treatment.
- •7) Patients with autoimmune disease or history of active autoimmune disease that has required systemic treatment
- •8) Patients treated with systemic steroids at doses higher than 10 mg/day of prednisolone equivalent for non- autoimmune diseases or patients treated with immunosuppressive agents.
- •9) Urgent radiotherapy because of symptom of superior vena cava syndrome.
- •10) Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom.
- •11) Patients with anamnesis of hypersensitivity to ingredients of the drug.
- •12) Any other patients who are regarded as unsuitable for this study by the investigators.
研究者
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