JPRN-jRCTs021220003招募中2 期
A phase II study of concurrent ipilimumab, nivolumab, and radiotherapy for advanced non-small cell lung cancer
Miyauchi Eisaku0 个研究点目标入组 40 人开始时间: 2022年4月19日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically or cytologically confirmed NSCLC
- •2) Have a histologic diagnosis of stage IIIB, IIIC, IV,or recurrent NSCLC.
- •3) No sensitizing EGFR mutations or known ALK alterations.
- •4) Patients must be planning to receive ipilimumab and nivolumab therapy.
- •5) Have at least one metastatic site for radiation therapy(30Gy/10Fraction).
- •6) Aged >=20, at the time of consent
- •7) ECOG PS 0-1
- •8) Have at least one measurable lesion outside the field of irradiation by CT or MRI per RECIST 1.1 criteria
- •9) Have adequate organ function
- •10) Patients must be expected to survive more than three months.
- •11) Ability to understand and the willingness to sign a written informed consent document
排除标准
- •1) Patients with sensitizing EGFR mutations or ALK alterations.
- •2) Patients with a past history of immunotherapy or radiation therapy.
- •3) Patients with symptomatic brain metastases.
- •4) Patients with an active autoimmune disease.
- •5) Patients with a past history of organ transplantation.
- •6) Patients with severe complications.
- •7) Patients with a known positive test for hepatitis B virus indicating acute or chronic infection.
- •8) Patients with interstitial lung disease by CT.
- •9) Patients with a condition requiring systemic treatment with corticosteroids.
- •10) Patients with pleural effusion requiring drainage.
- •11) Patients who are pregnant or lactating.
- •12) Patients with a past history of drug hypersensitivity.
- •13) Patients who have additional active malignancies.
- •14) Patients who are judged inappropriate for the clinical trial by doctors.
研究者
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