JPRN-jRCTs031180214已完成2 期
Phase II clinical study of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer.
Kubota Kaoru0 个研究点目标入组 81 人开始时间: 2019年3月8日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
研究概览
简要总结
Both 100 mg/m2 and 70 mg/m2 of nab-paclitaxel monotherapy are active for patients with previously treated advanced NSCLC with better safety profile and numerically favored OS and ORR for 70 mg/m2 dose. Therefore, 70 mg/m2 would be the optimal dose of nab-paclitaxel for NSCLC. nab-PTX 70 mg/m2 should be considered the standard option for patients receiving nab-PTX monotherapy.
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 non-small cell lung cancer.
- •2) Clinical stage IIIB, IV or post-operative recurrence.
- •3) Age 20 years or older.
- •4) ECOG Performance Status (PS) 0 to 1.
- •5) At least one mesurable lesion according to RECIST version 1.1.
- •6) Patients treated with at least one platinum regimens
- •7) With adequate organ function,
- •-neutrophil count over 1,500 / mm3,
- •-platelet count over 100,000 / mm3,
- •-hemoglobin concentration over 9.0 g / dL,
- •-kidney (creatinine within 1.5 mg / dL),
- •-liver (AST/ALT within 2.5 times less than ULN,
- •-total bilirubin within 1.5 mg/dL),
- •-peripheral neuropathy within Grade1, PaO2over 60 Torr or SpO2 over 94.
- •8) Life expectancy of more than three months.
- •9) Provided written consent in person for participation in this study.
排除标准
- •1) Patient with previous treatment by paclitaxel.
- •2) Patient receiving chemotherapies less than 4 weeks or EGFR-TKI within two weeks.
- •3) Patient receiving definitive radiotherapy for less than 6 weeks or local palliative radiotherapy for less than 2 weeks.
- •4) Patient with symptomatic brain metastasis.
- •5) Patient with need of chest drainage for pleural effusion.
- •6) Active infection.
- •7) Patient with severe complications.
- •8) Patient having autoimmune disease to need treatment by the immunosuppressive drug.
- •9) Patient with active multiple cancers.
- •10) Female Patient in or having a chance or planning of pregnancy or breast feeding. Male patient in planning to impregnate.
- •11) History of sever psychological disease.
- •12) Administering steroid.
- •13) Any patients judged by the investigator to be unfit to participate in the study.
研究者
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