NCT07464756招募中2 期
A Prospective Exploratory Study of SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年4月3日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
详细描述
This study enroll patients with resectable, locally advanced (cT3-4aN+M0) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received anticancer therapy. Eligible subjects will be randomized in a 1:1 ratio to one of the two intervention arms. Arm 1：SHR-1701, apatinib, and SOX. Arm2: SHR-1701 and SOX. Arm 1 incorporates a safety run-in phase, during which the first 6 subjects enrolled in this cohort will undergo safety observation.
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
- None
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
- •Patients voluntarily participate in this study and provide signed informed consent;
- •Age ≥18 years old;
- •Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);
- •Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable
- •No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
- •Plan to proceed to surgery after completion of neoadjuvant therapy;
- •Able to swallow tablets normally;
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Estimated life expectancy ≥12 months;
- •Has adequate organ function.
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 6 months after chemotherapy (whichever is longer). Male subjects with partners of childbearing potential must be surgically sterile or agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 3 months after chemotherapy (whichever is longer), and must not donate sperm during the study.
排除标准
- •Known HER2 positive
- •Need transthoracic surgical approach Based on the investigator's judgment
- •Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 4 Presence of unresectable factors, including unresectability due to tumor-related reasons, contraindications to surgery, or refusal of surgery;
- •5. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast;
- •Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)；
- •Known hypersensitivity to any of the study drugs or excipients;
- •Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
- •Congenital or acquired immune deficiency (e.g. HIV infected)
研究组 & 干预措施
SHR-1701 and SOX
Experimental
干预措施: SHR-1701 (Drug)
SHR-1701, apatinib, and SOX
Experimental
干预措施: apatinib (Drug)
SHR-1701, apatinib, and SOX
Experimental
干预措施: S-1 & Oxaliplatin (Drug)
SHR-1701, apatinib, and SOX
Experimental
干预措施: SHR-1701 (Drug)
SHR-1701 and SOX
Experimental
干预措施: S-1 & Oxaliplatin (Drug)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
次要结局
- Event free survival (EFS)(Up to approximately 4 years)
- Disease-free survival (DFS)(Up to approximately 4 years)
- Tumor Regression Grade (TRG)(Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment)
- Overall survival(OS)(Up to approximately 4 years)
- ypN staging(Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment)
- AEs(Up to approximately 3 years)
- R0 resection rate(Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid TumorsNCT07268040Shanghai Hengrui Pharmaceutical Co., Ltd.400
进行中（未招募）
2 期
A Study of SHR-1819 in Patients With Moderate-to-severe Atopic DermatitisNCT07321951Guangdong Hengrui Pharmaceutical Co., Ltd201
尚未招募
不适用
A Study of SHR-A1811 Combined With Adebelimumab as Neoadjuvant Therapy for Resectable HER2-Altered Non-Small Cell Lung CancerNSCLCNCT07281209Shanghai Chest Hospital40
进行中（未招募）
2 期
Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute PancreatitisNCT07308392Fujian Shengdi Pharmaceutical Co., Ltd.119
招募中
2/3 期
Study of HSSH-062501 Tablets in People with Mild to Moderate Chronic Joint PainCTRI/2025/11/097144Himalaya Wellness Company300