NCT03558191已完成2 期
A Single-arm, Open Label, Multi-center, Phase 2 Study of SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Patients Who Have Received Previous At Least Two Lines of Chemotherapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) Assess by Independent Review Committee (IRC)
研究概览
简要总结
This is an open label, single-arm, multi-center, phase 2 Study of SHR-1210 in recurrent/metastatic nasopharyngeal carcinoma(R/M NPC) patients who have received previous at least two lines of chemotherapy.
详细描述
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with R/M NPC. The secondary objective is to observe the duration of response, progression free survival, time to response, overall survival and safety of SHR-1210 in R/M NPC. ADA is also investigated.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma (WHO type II-III);
- •Stage IVb R/M NPC failed from first-line platinum based chemotherapy and second-line chemotherapy;
- •ECOG performance status of 0 or 1;
- •Life expectancy ≥ 12 weeks;
- •Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;
- •Can provide either a newly obtained or archival tumor tissue sample;
- •Adequate laboratory parameters during the screening period as evidenced by the following:
- •Absolute neutrophil count ≥ 1.5 × 10^9/L ;
- •Platelets ≥ 90 × 10^9/L;
- •Hemoglobin ≥ 9.0 g/dL;
- •Serum albumin ≥ 2.8g/dL;
- •Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 1.5×ULN
- •Creatinine clearance≥50 mL/min;
- •Female of child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 60 days after the last dose of SHR-
- •Male subjects with WOCBP partner must be willing to use adequate contraception for the course of the study through 120 days after the last dose of SHR-1210;
- •Subjects must be willing to participate in the research and sign an informed consent form (ICF);
排除标准
- •Subjects with any active autoimmune disease or history of autoimmune disease;
- •Subjects having clinical symptoms of metastases to central nervous system (such as cerebral edema, requiring steroids intervention, or brain metastasis progression);
- •Has a known additional malignancy within the last 5 years before study treatment with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers;
- •Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- •Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalent for replacement therapy;
- •Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy within 4 weeks prior to first dosing or not recovered to ≤CTCAE 1 from adverse events (except for hair loss or neurotoxic sequelae from prior platinum therapy) due to a previously administered agent. Palliative irradiation should be ended 2 weeks before first dosing;
- •Active infection or an unexplained fever > 38.5°C before two weeks of first dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
- •Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C;
- •Currently participating or has participated in a study within 4 weeks of the first dose of study medication;
- •Received a live vaccine within 4 weeks of the first dose of study medication. Pregnancy or breast feeding;
- •Received a systematic antibiotics within 4 weeks of the first dose of study medication.
- •Pregnancy or breast feeding.
- •Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;
- •Subjects are known to have a history of psychiatric substance abuse, alcoholism, or drug addiction;
- •Pregnancy or breast feeding;
- •According to the investigator, other conditions that may lead to stop the research.
研究组 & 干预措施
SHR-1210 Injection
Experimental
SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes, once every 2 weeks .
干预措施: SHR-1210 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Assess by Independent Review Committee (IRC)
时间窗: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death ，whichever was earlier, approximately 3 years.
Percentage of participants achieved partial response (PR) or complete response (CR) based on IRC assessment according to the RECIST (version 1.1) is presented for this endpoint. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response .
次要结局
- Overall Survival (OS)(Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.)
- ORR Assess by Investigators(Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.)
- Duration of Response (DoR)(Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.)
- Disease Control Rate (DCR)(Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.)
- Progression-Free Survival (PFS)(Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.)
研究者
研究点 (1)
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