NCT04405622进行中（未招募）2 期
Toripalimab Combined With Gemcitabine in Recurrent or Metastatic Nasopharyngeal Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年5月30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
- 进行中（未招募）
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is an open-label, single center, pilot trial to evaluate the safety and efficacy of toripalimab and gemcitabine in patients with recurrent or metastatic nasopharyngeal carcinoma.
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
- •Male or female; 18-70 years of age.
- •Subjects diagnosed with pathological confirmed metastatic nasopharyngeal carcinoma, or subjects with recurrent NPC that is unfit for local treatment.
- •did't receive any systemic chemotherapy for recurrent and metastatic lesions.
- •Intolerance to or rejection of platinum-based chemotherapy
- •ECOG performance status of 0 or
- •Life expectancy more than 12 weeks.
- •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
- •Female subjects agree not to be pregnant or lactating from beginning of the study screening through at least 3 months after receiving the last dose of study treatment. Both men and women of reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy. A highly effective method of contraception is defined as one that results in a low failure rate, that is, less than 1% per year when used consistently and correctly
- •Able to understand and sign an informed consent form (ICF).
排除标准
- •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°C 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
Toripalimab plus gemcitabin arm
Experimental
Subjects receive gemcitabine and toripalimab.
干预措施: Toripalimab plus gemcitabine (Drug)
结局指标
主要结局
Adverse events
时间窗: 1 year
The safety will be assessed according to CTCAE (V5.0)
次要结局
- The proportion of patients who achieved an objective response(1 year)
- The proportion of patients who achieved disease control(1 year)
- The proportion of patients who achieved clinical benefit(1 year)
- Progression-free survival(1 year)
- Duration of response(1 year)
研究者
Ming-Yuan Chen
Chief physician, Proffessor
Sun Yat-sen University
研究点 (1)
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