A Randomized, Double-Blind, Multi-Center, Phase III Clinical Study of SHR-1701 Plus Chemotherapy Versus Placebo Plus Chemotherapy as Treatment in Patients With Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 737
- 试验地点
- 1
- 主要终点
- AEs and SAEs in part 1 study
研究概览
简要总结
This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. For Part 1 study，the tolerability of SHR-1701 will be evaluated and determine the recommended dose for Part 2.For Part 2 study, all enrolled patients will be randomized to 2 groups and continuously treated until the end criteria of treatment was met.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Pathologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ)adenocarcinoma.
- •HER2 overexpression or amplification negative.
- •Female or male, 18 years of age or above.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 -
- •Patients who are willing and able to provide the signed informed consent form, willing and able to comply with all the scheduled visits, study treatment, laboratory tests, and other study procedures.
排除标准
- •Squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer.
- •Presence of inadequately treated CNS metastases, or uncontrolled or symptomatic active CNS metastases ，leptomeningeal disease, and/or rapid progression.
- •Presence of uncontrolled pleural effusion or ascites despite puncture drainage within 14 days prior to randomization.
- •More than 20% weight loss within 2 months prior to randomization.
- •Diagnosed with other malignant tumors within 5 years prior to enrollment.
- •Presence of any active, known or suspected autoimmune disease.
- •Prior treatment with TGF-β inhibitor, anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies.
- •Severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.
研究组 & 干预措施
Treatment group A
干预措施: SHR-1701、CAPOX (Drug)
Treatment group B
干预措施: Placebo、CAPOX (Drug)
结局指标
主要结局
AEs and SAEs in part 1 study
时间窗: up to 2 years
The number and proportion of subjects with dose limiting toxicity. The safety endpoints, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Overall survival in subjects with PD-L1 CPS ≥ 5 in part 2 study
时间窗: up to 3 years
OS in all subjects in part 2 study
时间窗: up to 3 years
Overall survival (OS)
次要结局
- EORTC QLQ-C30 score(up to 2 years)
- PFS in part 1 study(up to 2 years)
- DoR in part 1 study(up to 2 years)
- DoR in part2 study(up to 2 years)
- ORR in part 1 study(up to 2 years)
- ORR in part 2 study(up to 2 years)
- EORTC QLQ-STO22 score(up to 2 years)
- EQ-5D-5L score(up to 2 years)
- DCR in part 1 study(up to 2 years)
- OS in part 1 study(up to 3 years)
- PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator as per RECIST 1.1(up to 2 years)
- DoR in part 2 study(up to 2 years)
- PFS in part 2 study(up to 3 years)
- DCR in part 2 study(up to 2 years)
- AEs and SAEs in part 2 study(up to 2 years)