NCT03755440已完成2 期
Phase II Study of PD-1 Antibody SHR-1210 in EBV Positive Metastatic Gastric Cancer Patients.
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
EBV positive tumor accounts for 8-9% of all gastric cancer (GC) patients. PD-1 antibody has been proved as third line therapy for PD-L1 positive gastric cancer. Previous studies showed that EBV(+) tumors exhibit high response to PD-1 antibody. In this phase II study, we will investigate the efficacy and safety of PD-1 antibody in EBV positive metastatic GC patients.
详细描述
EBV positive metastatic GC patients who failed to standard chemotherapy will receive therapy of single agent, PD-1 antibody, SHR-1210, 200mg, every 2 weeks. The primary endpoint is response rate. Secondary endpoint is progress free survival, overall survival, safety and quality of life. Using the Simon two-stage sample size calculation, the sample size is 19. We will collect tissue and blood sample for exploratory analysis, including PD-L1 stuatus, tumor mutation burden, et al.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Recurrent/Metastatic gastric adenocarcinoma;
- •EBER positive;
- •Failed from first-line platinum and fluorouracil based chemotherapy and second-line chemotherapy; or could not tolerate systematic 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 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 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 finished within 2 weeks;
- •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;
- •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;
- •According to the investigator, other conditions that may lead to stop the research.
研究组 & 干预措施
PD-1 antibody
Experimental
SHR-1210, 200mg, ivdrip, d1, every two weeks.
干预措施: PD-1 antibody (SHR-1210) (Drug)
结局指标
主要结局
Response rate
时间窗: From first patient first visit to 6 month after last patient first visit ] Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
The percentage of patients whose cancer shrinks or disappears after treatment
次要结局
- Progression-Free Survival (PFS)(up to approximately 1 year)
- Overall Survival (OS)(up to approximately 2 year)
- Disease Control Rate (DCR)(From first patient first visit to 6 month after last patient first visit)
研究者
Ruihua Xu
Professor
Sun Yat-sen University
研究点 (1)
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