PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab for Patients With Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: A Single Center, Single Arm, Phase II Clinical Study.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy.
详细描述
To evaluate the efficacy and safety of sintilimab combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma (NPC) after platinum-based chemotherapy failure. The primary end point is objective response rate (ORR), the secondary end points are overall survival (OS), progression-free survival (PFS), duration of response (DOR), adverse effects and quality of life.
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
- •Patients diagnosed with metastatic nasopharyngeal carcinoma are not suitable for radical local treatment.
- •Previous failure of first-line platinum-containing chemotherapy (single drug or combination).
- •Previously diagnosed WHO classification type II or III by histological pathology.
- •At least one measurable lesion (according to RECIST1.1).
- •Age between 18 and
- •Eastern Cooperative Oncology Group (ECOG) 0-1, and life expectation at least 3 months.
- •Enough blood test.
- •Participate voluntarily and sign the informed consent.
排除标准
- •Previously diagnosed WHO classification type I by histological pathology.
- •Prior exposure to anti-PD-1/PD-L1 antibodies plus anti-VEGF antibodies.
- •Necrotizing lesions were found within the first 4 weeks, or the risk of massive bleeding.
- •A history of interstitial pneumonia or other autoimmune diseases.
- •Sever infection.
- •Sever heart disease.
- •HIV infection.
- •Allogeneic organ transplantation
- •Malignancy other than nasopharyngeal carcinoma.
- •Pregnancy or breast feeding.
- •Received other test drugs.
研究组 & 干预措施
PD-1 immune checkpoint inhibitor combined with bevacizumab
干预措施: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: 2 years
The proportion of patients whose tumors shrink by a certain amount and remain in place for a certain amount of time, including complete response (CR) and partial response (PR).
次要结局
- overall survival (OS)(2 years)
- progression-free survival (PFS)(2 years)
- duration of response (DOR)(2 years)
研究者
XIANG YANQUN
professor
Sun Yat-sen University