NCT04342910招募中3 期
A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Overall Survival (OS) in PD-L1 Positive Participants.
研究概览
简要总结
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
- •Confirmed metastatic or locally advanced, unresectable disease.
- •Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.
- •Willing to provide tumor tissue for PD-L1 biomarker analysis.
- •Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab.
- •ECOG performance status of 0 to
- •Life expectancy of more than 12 weeks.
- •Signing the informed consent forms.
- •Adequate bone marrow, liver and renal function.
排除标准
- •Squamous cell or undifferentiated gastric cancer.
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
- •Clinically significant cardiovascular and cerebrovascular diseases.
- •Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
- •Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
- •Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
- •Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
- •Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
研究组 & 干预措施
camrelizumab (SHR-1210) combined with apatinib
Experimental
Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years.
干预措施: camrelizumab (Drug)
camrelizumab (SHR-1210) combined with apatinib
Experimental
Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years.
干预措施: Apatinib Mesylate (Drug)
Paclitaxel or Irinotecan
Active Comparator
Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle, or irinotecan on Days 1 and 15 of each 28-day cycle.
干预措施: Paclitaxel (Drug)
Paclitaxel or Irinotecan
Active Comparator
Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle, or irinotecan on Days 1 and 15 of each 28-day cycle.
干预措施: Irinotecan (Drug)
结局指标
主要结局
Overall Survival (OS) in PD-L1 Positive Participants.
时间窗: Up to 27 months
OS was defined as the time from randomization to death due to any cause.
次要结局
- Overall Survival (OS) in All Participants.(Up to 27 months)
- Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants.(Up to 27 months)
- Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.(Up to 27 months)
- Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants(Up to 27 months)
- Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants.(Up to 27 months)
- Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.(Up to 27 months)
- Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.(Up to 27 months)
- Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.(Up to 27 months)
- The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.(Up to 27 months)
- Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.(Up to 27 months)
- Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline(Up to 27 months)
- Serum concentration of camrelizumab(Up to 27 months)
- Plasma concentration of apatinib(Up to 27 months)
研究者
研究点 (1)
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