NCT06247956进行中（未招募）2 期
A Randomized, Open, Multicenter Phase II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the First-line Treatment of Advanced Gastric and Esophageal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- ORR based on RECIST v1.1 assessment.
研究概览
简要总结
Objective response rate (ORR) was evaluated to evaluate the efficacy of SHR-8068 combined with adebrelimab and platinum-containing chemotherapy in first-line treatment of advanced gastric and esophageal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
- •Aged 18-75 at the time of signing the informed consent;
- •Histologically or cytologically confirmed, unresectable, advanced or recurrent/metastatic adenocarcinoma of the gastric or gastroesophageal junction, or unresectable or recurrent/metastatic esophageal squamous cell carcinoma without radical chemoradiation;
- •At least one measurable lesion consistent with RECIST v1.1;
- •ECOG PS score: 0-1;
- •The organ function level is good;
排除标准
- •Her2-positive patients;
- •Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
- •Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
- •Previous or co-existing malignant neoplasms;
- •The presence of any active or known autoimmune disease;
- •People who have previously received an organ transplant;
- •Have clinical symptoms or diseases of the heart that are not well controlled;
- •Known allergic reactions to adebrelimab or other monoclonal antibodies or investigational drugs;
研究组 & 干预措施
SHR-8068 combined with adebrelimab and platinum-containing chemotherapy
Experimental
干预措施: SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection (Drug)
Adebrelimab combined with platinum-containing chemotherapy
Active Comparator
干预措施: Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection (Drug)
结局指标
主要结局
ORR based on RECIST v1.1 assessment.
时间窗: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years
次要结局
- DCR based on RECIST v1.1 assessment(All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years)
研究者
研究点 (1)
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