Phase II Trial of Carboplatin, Etoposide and Atezolizumab for Previously Untreated Elderly Patients with Advanced Small cell lung cancer (OLCSG 2002-EPAS trial) - OLCSG 2002-EPAS trial

Kato Yuka0 个研究点目标入组 32 人开始时间: 2020年10月23日最近更新: 2023年11月20日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 32

研究概览入排标准研究者记录与标识符相似试验

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: >= 71age old 至 ot applicable（—）
性别: All

入选标准

•1) A definitive diagnosis of small cell lung cancer has been obtained by histology or cytology.
•2) Diagnosed as advanced type (ED) by chest CT, head CT or MRI, PET-CT, etc.
•3) No serious tumor-related complications.
•4) The age of the registration date is 71 years or older.
•5) Performance status (PS) is 0-2 according to the ECOG standard.
•6) Has measurable lesions.
•7) No history of surgery, radiation therapy, or chemotherapy for small cell lung cancer.
•8) No surgery, chest radiation therapy, or chemotherapy within 1 year for other cancers.
•9) The general condition is good, and the functions of blood, kidney, liver, etc. can be maintained.
•10) Patient consent is obtained in writing from the patient.

排除标准

•1) Patients with positive HIV antibody.
•2) Patients who are HCV antibody positive and HCV-RNA positive.
•3) Patients positive for HBs antigen, HBc antibody or HBs antibody.
•4) Patients with autoimmune diseases including past medical history.
•5) Patients with complications such as active interstitial lung disease and active radiation pneumoni
•6) Patients with tuberculosis.
•7) Patients undergoing dialysis.
•8) Patients with severe liver dysfunction.
•9) Patients with severe impairment of cardiovascular system and respiratory function.
•10) Patients with a history of Grade 3 or higher hypersensitivity to immune checkpoint inhibitors, ca
•rboplatin or etoposide.
•11) Patients with endocrine disorders that are difficult to control.
•12) Patients with active inflammatory bowel disease.
•13) Patients who receive continuous systemic administration of steroids over 5 mg/day in terms of predonin.
•14) Patients with uncontrolled diabetes (HbA1c 8.0% or more).
•15) Patients in need of double cancer treatment.
•16) Patients who cannot consent to contraception by contraception methods such as condoms for 6 months after the consent is obtained and the therapeutic drug administration is completed.
•17) Patients with severe infections.
•18) Patients with mental disorders or dementia who have trouble obtaining proper consent.
•19) Patients who have undergone transplantation therapy such as hematopoietic stem cell transpla ntation.
•20) Patients who are judged to be unsuitable by the investigator or investigator.

研究者

发起方

Kato Yuka

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