NCT03582527Unknown不适用
The Expression of Programmed Death Ligand-1 (PD-L1) on Advanced Osteosarcoma Tissue and Its Influence on Prognosis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- PD-L1 expression level
研究概览
简要总结
The expression level of PD-L1 on tumor cells is a pivotal point which might have some influence on prognosis, especially for those who might use PD-1 or PD-L1 antibody for treatment. The aim of this study is to detect the expression of PD-1 on advaced osteosarcoma patient who might use these antibodies for treatment. All those specimen should be taken by pathologist and confirmed with high tumor cellularity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis confirmed histologically and reviewed centrally;
- •received surgery in Musculoskeletal Tumor Center of Peking University People's Hospital with appropriate sample for immunohistochemical staining;
- •progressing upon prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
- •having measurable lesion according to RECIST 1.1;
- •Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months;
- •intend to receive anti-PD-1/anti-PD-L1 antibody for therapy.
排除标准
- •fail to be followed up regularly.
- •sample disqualification.
结局指标
主要结局
PD-L1 expression level
时间窗: 2 months
all those specimens will be tested for expression level,Tumors with ≥50% cells showing positive membrane staining were considered to have high expression of PD-L1
次要结局
- progression free survival(2 years)
- overall survival(5 years)
研究者
研究点 (1)
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