NCT04070040招募中2 期
An Exploratory Study on Camrelizumab（SHR-1210）for Recurrent Primary Central Nervous System Lymphoma (PCNSL)
Beijing Sanbo Brain Hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年2月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- ORR(objective response rate)
研究概览
简要总结
This study is intend to improve the objective response rate in treatment of camrelizumab in recurrent primary central nervous system lymphoma patients.
详细描述
Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with recurrent PCNSL remains challenging and at present there is no universally accepted therapeutic approach . The purpose of this study is to evaluate the efficacy and safety of camrelizumab [a programmed cell death 1 (PD-1) inhibitor] for recurrent patients with primary CNS lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The initial diagnosis was primary diffuse large B-cell lymphoma of the central nervous system confirmed by histopathology;
- •Prior to first-line treatment based on methotrexate (with or without radiotherapy), tumor recurrence was confirmed by MRI;
- •Measurable focus in MRI (>10x10mm);
- •Aged > 18 years;
- •Life expectancy of at least 12 weeks;
- •The patient has a Karnofsky performance status of at least 50%;
- •Main organs function normally, without serious blood, heart, lung, liver, kidney and immune deficiency diseases. Specific assay indicators requirements： White blood cells>3.0×10^9/L;platelet>80×10^9/L;hemoglobin>10g/dL;serum bilirubin ≤ 1.5×ULN;ALT and AST ≤ 2×ULN;serum creatinine≤1.5mg/dL;
- •Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration;
- •The subject should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form;
排除标准
- •Concurrent administration of any other antitumor therapy；
- •Allergic to the ingredients of research drugs；
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent；
- •Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function；
- •Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except for a maximum dose of 4 mg/day dexamethasone or equivalent doses of other corticosteroids or control of brain edema, which has been stable or decreased for at least 1 week prior to inclusion;
- •Active infection;
- •Risk of bleeding;
- •HIV positivity;
- •Pregnancy and lactation;
研究组 & 干预措施
Camrelizumab
Experimental
Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.
干预措施: Camrelizumab (Drug)
结局指标
主要结局
ORR(objective response rate)
时间窗: Up to three years
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
次要结局
- OS(overall survival)(Up to three years)
- The best therapeutic response of CR(complete response)、PR(partial response)、SD(stable response) and PD(progressive disease)(Up to three years)
- ADEs( adverse events)(Up to three years)
- KPS(Karnofsky Performance Status)(Up to three years)
- PFS(progression free survival)(Up to three years)
研究者
Junping Zhang
Beijing Sanbo Brain Hospital
Beijing Sanbo Brain Hospital
研究点 (1)
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