NCT05724355招募中2 期
Dalpiciclib Combined With Camrelizumab for PD-1 Inhibitor Refractory R/M NPC
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年9月1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
- 32
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC.
- •ECOG performance status of 0 or
- •Progression after previous treatment with platinum-based dual-drug chemotherapy.
- •Progression after previous treatment with PD-1 inhibitors.
- •Experieced at least 1 line systemic therapy.
- •Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.
- •Adequate organ function assessed by laboratory parameters during the screening period.
- •Life expectancy more than 12 weeks.
- •Able to understand and sign an informed consent form (ICF).
- •Able to swallow the pill.
排除标准
- •Recurrent lesions suitable for radical treatment (radiotherapy or surgery).
- •Previous treatment over 3 lines.
- •Prior use of CDK4/6 inhibitors.
- •Patients with other malignancies.
- •Patients with known or suspected autoimmune diseases including dementia and seizures.
- •Multiple factors affecting the absorption of oral medications (e.g., dysphagia, chronic diarrhea, and bowel obstruction).
- •An excessive dose of glucocorticoids given within 4 weeks before enrollment.
- •Complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids.
- •Patients with active pulmonary tuberculosis (TB) receiving anti-TB treatment or who have received anti-TB treatment within 1 year prior to screening.
- •HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibody positive).
- •Any anti-infective vaccines such as influenza vaccine, varicella vaccine, etc., within 4 weeks before enrollment.
- •Women of childbearing age with a positive pregnancy test and lactating women.
研究组 & 干预措施
Dalpiciclib plus Camrelizumab
Experimental
干预措施: Dalpiciclib Isetionate Tablets, Camrelizumab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 1 year
Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.
次要结局
- Duration of response (DoR)(1 year)
- Disease control rate (DCR)(1 year)
- Median progression-free survival (PFS)(1 year)
- Median overall survival (OS)(3 years)
- Incidence of adverse events(1 year)
研究者
Ming-Yuan Chen
Chief physician, Professor
Sun Yat-sen University
研究点 (1)
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