Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of Camrelizumab plus pyrotinib in combination with chemotherapy in patients with HER2-positive gastric cancer.
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
- •Age 18 years or older.
- •Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma.
- •Patients have not received systemic treatment in the past but had disease progression more than 6 months after receiving neoadjuvant therapy or the last of adjuvant therapy could be enrolled or failure of first-line therapy or completion of (new) adjuvant therapy to disease recurrence less than 6 months.
- •HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with fluorescent in-situ hybridization (FISH+ is defined as HER2:CEP17 ratio≥2.0), as assessed by central review on primary or metastatic tumor.
- •ECOG performance status 0-
- •At least one measurable lesion exists as defined by RECIST 1.1 .
- •Life expectancy of more than 12 weeks.
排除标准
- •Hypersensitivity to Camrelizumab, pyrotinib and study chemotherapy agents and/or to any components.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, Cluster of Differentiation 137 [CD137]).
- •Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •Has a known history of Human Immunodeficiency Virus (HIV) or active hepatitis B and C virus infection.
- •Has had major surgery within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment.
- •Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
- •Evidence or history of coagulation disorders such as a grade ≥ 3 (CTC-AE) bleeding event.
- •Known history of psychotropic substance abuse or drug use.
研究组 & 干预措施
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously [IV] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily [QD] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
干预措施: Camrelizumab (Drug)
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously [IV] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily [QD] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
干预措施: Pyrotinib (Drug)
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously [IV] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily [QD] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
干预措施: Capecitabine (Drug)
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously [IV] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily [QD] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
干预措施: Oxaliplatin (Drug)
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously [IV] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily [QD] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
干预措施: Paclitaxel (Drug)
Camrelizumab+Pyrotinib + Chemotherapy
Camrelizumab (200 mg) will be administered intravenously [IV] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily [QD] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
干预措施: S-1 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: [ Time Frame: Up to approximately 2 years ]
Objective response rate assessed at 18 weeks after enrollment，that is about 6 cycles of treatment
次要结局
- Overall Survival (OS)([ Time Frame: Up to approximately 2 years ])
- Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR([ Time Frame: Up to approximately 2 years ])