NCT04140318Unknown2 期
Efficacy and Safety of Sintilimab and Nab-paclitaxel in Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma Patients With Progression After Fluoropyrimidine or Platinum, a Multi-center, Phase II, Single Arm Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.
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
- •pathological confirmed advanced gastric and gastro-esophageal junction adenocarcinoma;
- •progression after first-line treatment of fluoropyrimidine and platinum, allow patients progressed on/within 6 months of neoadjuvant/adjuvant treatment; allow local radiotherapy after 21days later;
- •18-75 years old;
- •ECOG: 0 or 1;
- •has adequate organ function
- •writen ICF;
排除标准
- •previous treated with taxanes (including paclitaxel, nab-PTX, lipo-PTX, and docetaxel etc..);
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody;
- •has known active central nervous system metastatases;
- •has received a live vaccine within 4 weeks prior to the first dose of study treatment with any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
- •clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), orventricular arrhythmia which need medical intervention.
- •hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg. coagulation abnormalities (INR > 1.5 or APTT > 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
研究组 & 干预措施
treatment
Experimental
combination therapy of PD-1 and chemotherapy including: sintilimab 200mg iv, 30-60min, q3w; nab-paclitaxel 125mg/m2, iv, d1,d8, q3w
干预措施: sintilimab (Drug)
treatment
Experimental
combination therapy of PD-1 and chemotherapy including: sintilimab 200mg iv, 30-60min, q3w; nab-paclitaxel 125mg/m2, iv, d1,d8, q3w
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
ORR
时间窗: up to two years
次要结局
- OS(up to three years)
- DCR(up to three years)
- DOR(up to three years)
- AE(from first dose to 90days of last dose)
- PFS(up to three years)
研究者
Aiping Zhou
Prof.
Chinese Academy of Medical Sciences
研究点 (1)
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