Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) Versus SOX Alone for Locally Advanced Gastric or GEJ Adenocarcinoma: A Multicenter Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Total pathological complete response (pCR; ypT0) assessed by investigators, defined as the complete absence of tumor cells in the primary tumor on pathological examination.
研究概览
简要总结
The purpose of this clinical trial is to evaluate whether perioperative ivonescimab in combination with S-1 and oxaliplatin (SOX) is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen.
Primary Objective:
To determine whether perioperative ivonescimab plus SOX improves the pathological complete response (pCR) rate compared with SOX alone in patients with locally advanced gastric or GEJ adenocarcinoma.
Study Design:
Participants will be randomly assigned to receive either ivonescimab plus SOX or SOX alone to evaluate the potential added benefit of ivonescimab in this setting.
Participation Details:
Participants will receive the assigned treatment (ivonescimab plus SOX or SOX alone) every 21 days for approximately 4 months.
They will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring.
Participants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.
详细描述
To evaluate the efficacy and safety of ivonescimab in combination with S-1 and oxaliplatin (SOX) for the treatment of locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in the neoadjuvant (perioperative) setting, with the goal of improving the pathological complete response (pCR) rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years.
- •Histologically confirmed gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Clinically staged as T3-4a N+ M0 by computed tomography (CT) or magnetic resonance imaging (MRI).
- •Considered eligible for curative resection.
- •No prior antitumor therapy for the current disease.
- •Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.
- •Expected survival of ≥6 months.
排除标准
- •Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.
- •Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled.
- •Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator.
- •History of thromboembolic or arterial/venous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.
- •Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.
研究组 & 干预措施
SOX
oxaliplatin, S-1, four 3-week cycles were administered.
干预措施: Oxaliplatin (Drug)
SOX
oxaliplatin, S-1, four 3-week cycles were administered.
干预措施: S-1 (Drug)
ISOX
In the ISOX group, the regimen included ivonescimab, oxaliplatin, and S-1.
干预措施: Ivonescimab (20mg/kg Q3W) (Drug)
ISOX
In the ISOX group, the regimen included ivonescimab, oxaliplatin, and S-1.
干预措施: Oxaliplatin (Drug)
ISOX
In the ISOX group, the regimen included ivonescimab, oxaliplatin, and S-1.
干预措施: S-1 (Drug)
结局指标
主要结局
Total pathological complete response (pCR; ypT0) assessed by investigators, defined as the complete absence of tumor cells in the primary tumor on pathological examination.
时间窗: Perioperative
次要结局
- Event-free survival (EFS)(Through study completion,an average of 2 years)
- major pathologic response(Perioperative)
- R0 resection(Perioperative)
- overall survival (OS)(Through study completion,an average of 2 years)
- disease-free survival (DFS)(Through study completion,an average of 2 years)
- safety(Through study completion,an average of 2 years)
- surgery-related complications(Through study completion,an average of 2 years)
- An exploratory endpoint(Through study completion,an average of 2 years)
- Quality of life(Perioperative)
研究者
Bo Zhang, MD
Chief Physician
Sichuan University