NCT04398056Unknown2 期
Chemotherapy Plus Subsequent Loco-regional Radiotherapy Combined With Toripalimab for the de Novo Metastatic Nasopharyngeal Carcinoma: a Single Center, Phase II Clinical Trial.
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年4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
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The purpose of this study is to preliminarily evaluate the efficacy and safety of chemotherapy plus subsequent loco-regional radiotherapy combined with toripalimab for the de novo metastatic nasopharyngeal carcinoma.
详细描述
This is a single center , single arm, phase II study. All eligible patients with the de novo metastatic NPC are treated with chemotherapy plus subsequent loco-regional radiotherapy combined with toripalimab. The primary objective of this study is to assess objective response rate of chemotherapy plus subsequent loco-regional radiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma . The secondary objective is to assess progression free survival, and Adverse events.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had histopathologically confirmed metastatic NPC that was diagnosed as stage IVb NPC as defined by the AJCC, 8th edition;
- •Patients evaluated to have a complete response (CR) or partial response (PR) by an imaging study after three cycles of cisplatin plus 5-fluorouracil (PF) chemotherapy;
- •Patients who did not receive any previous systemic chemotherapy;
- •Patients with a Karnofsky performance status (KPS) score of at least 70;
- •Patients with adequate organ function (white blood cell count of at least 4.0x109 per L; absolute neutrophil of at least 2.0x109 per L; hemoglobin concentrations of at least 90 g/L; platelet cell count of at least 100 x109 per L; aspartate transaminase and alanine transaminase levels less than 2.5 times the upper limit of the normal value; and creatinine clearance rate of at least 60 mL/min);
- •Patients who provided written informed consent;
- •Patients who agree to regular follow-up visits.
排除标准
- •Patients with recurrent mNPC who received prior definitive radiotherapy/chemoradiotherapy;
- •Patients with life-threatening medical disorders;
- •Patients who were pregnant or breastfeeding;
- •Patients with other invasive malignant diseases within the past 5 years, other than excised basal-cell skin carcinoma, cervical carcinoma in situ, superficial bladder tumors (Ta, Tis, and T1);
- •Patients with serious comorbidities.
- •Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval;
- •Known history of hypersensitivity to any components of the Toripalimab formulation;
- •Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed;
- •Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease);
- •Uncontrolled clinically significant medical condition, including but not limited to the following:
- •congestive heart failure (New York Health Authority Class > 2);
- •unstable angina;
- •myocardial infarction within the past 12 months;
- •clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
- •Active infection or an unexplained fever; 38.5℃ during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled);
- •History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease;
- •Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results;
- •Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation based on institutional guidelines and tests. Testing may include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody.
研究组 & 干预措施
Chemotherapy plus radiotherapy and Toripalimab
Experimental
Patients were treated with PF chemotherapy for a maximum of six cycles followed by loco-regional radiotherapy combined with toripalimab.
干预措施: Chemotherapy plus radiotherapy and Toripalimab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 1 year
The proportion of patients who achieved an objective response, defined as those with radiologically confirmed complete or partial response according to RECIST 1.1 assessed by the investigator;
次要结局
- Disease Control Rate(1 year)
- Progression-free survival(1 year)
- The toxicity grade will be assessed according to CTCAE 5.0.(1 year)
研究者
Ming-Yuan Chen
professor & chief physician
Sun Yat-sen University
研究点 (1)
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