Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer.
详细描述
Although anti-PD-1 antibody could prolong the survival of patients with adanced gastic cancer, there are relatively few reports on anti-PD-1 antibody therapy in Her2-positive gastric cancer. RC48 is a primary anti-HER2 antibody-drug conjugate, which has been approved by the Chinese NMPA for the later-line treatment of Her2-positive gastric cancer. This study was to explore the safety and clinical efficacy of RC48 combined with cisplatin and AK105 in previously untreated 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 old, ≤75 years old, regardless gender
- •Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+
- •ECOG PS scores 0-1
- •Stage IV according to AJCC 8.0 and no systemic therapy previously
- •Expected lifespan ≥ 3 months
- •Adequate organ function
- •At least one measurable lesion according to RECIST 1.1
- •Asymptomatic intracranial metastasis
- •No history of other malignancies
- •Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the trial and for 6 months after the trial
- •Agreed to participate in this clinical study and signed the Informed Consent
排除标准
- •Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose
- •Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor
- •Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration
- •Active autoimmune diseases or immunodeficiency diseases
- •Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug
- •Severe mental disorder
- •Receiving systemic corticosteroids within 7 days prior to the first dose of the study
- •Clinically apparent cardiovascular and cerebrovascular disease
- •Others investigators evaluated not meet the inclusion criteria
研究组 & 干预措施
exprimental group
RC48 plus AK105 and cisplatin
干预措施: RC48+AK105+cisplatin (Drug)
结局指标
主要结局
ORR
时间窗: three months
the proportion of patients who got CR and PR
次要结局
- DCR(three months)
- PFS(six months and twelve months)
研究者
Quanli Gao
Dr
Henan Cancer Hospital