Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With Gastric Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Arms 1: Neoadjuvant therapy group
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of sintilimab+ IBI310 for EBV-Positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ malignant tumor (including squamous carcinoma, adenocarcinoma, Signet-ring cell carcinoma).
- •Confirmed EBV positive determined by in situ hybridization (ISH), analyzed with tumor tissue sample, either from a previous surgery or biopsy , within last 6 months
- •Male or Female at least 18 years of age
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Has adequate organ function.
- •Expected survival>=12 weeks
- •Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at the timing of enrollment.
- •Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication.
- •Applied to Arms 1: Has histologically confirmed gastric/GEJ malignant tumor, and were regarded as having clinical stage T3-T4aN0M0 or T2～4aN+M0
- •Applied to Arms 2: Had no prior systemic treatment for metastatic disease.
- •Applied to Arms 3: Received ≥1 prior systemic treatment for metastatic disease.
排除标准
- •Has received prior therapy with an anti-programmed death (PD)-1, antiPD-L1, anti-PD L2, anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- •Is currently participating in and receiving study therapy ,except those in the survival follow up period of an investigational agent study or non-interventional study .
- •Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic reaction of i.v. contrast agent are permitted in the absence of active autoimmune disease.
- •Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
- •Has had major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to first dose of study medication, or anticipation of the need for major surgery during the course of study treatment
研究组 & 干预措施
Neoadjuvant therapy group
干预措施: Sintilimab (Drug)
Neoadjuvant therapy group
干预措施: IBI310 (Drug)
first-line therapy group
干预措施: Sintilimab (Drug)
first-line therapy group
干预措施: IBI310 (Drug)
≥second-line therapy group
干预措施: Sintilimab (Drug)
≥second-line therapy group
干预措施: IBI310 (Drug)
结局指标
主要结局
Arms 1: Neoadjuvant therapy group
时间窗: Approximately 40 months after the first participant is randomized
Pathological complete regression (pCR): Pathological complete regression (pCR) is defined as the proportion of patients with pathological complete regression (TRG1a) over the total number of patients evaluated centrally by the study pathologist
Arms 2: first-line therapy group
时间窗: Approximately 40 months after the first participant is randomized
Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
Arms 3:≥second-line therapy group
时间窗: Approximately 40 months after the first participant is randomized
Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
次要结局
- Arms 2: first-line therapy group(Approximately 40 months after the first participant is randomized)
- Arms 3:≥second-line therapy group(Approximately 40 months after the first participant is randomized)
- Arms 1: Neoadjuvant therapy group(Approximately 40 months after the first participant is randomized)
研究者
Shen Lin
MD,Professor,Chief of Department of GI Oncology,Peking University Cancer Hospital
Peking University