NCT07151209尚未招募2 期
A Prospective, Multicenter, Open-label Phase II Single-arm Clinical Trial Protocol on the Efficacy and Safety of Lparomlimab and Tuvonralimab in Combination With Lenvatinib and SOX Chemotherapy in Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Pathological complete response (pCR) rate
研究概览
简要总结
Efficacy and safety of Iparomlimab and Tuvonralimab in combination with lenvatinib and SOX chemotherapy in potentially resectable MSI-H, dMMR locally advanced gastric or gastroesophageal junction adenocarcinoma patients: A prospective, multicenter, open-label Phase II single-arm clinical trial
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
- •Able to understand and agree to comply with study requirements and the assessment schedule, and voluntarily sign the written informed consent form (ICF) before any trial-related procedures are implemented;
- •Age greater than 18 years, regardless of gender. Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma.
- •No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma. Previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 6 months prior to the diagnosis of unresectable or metastatic disease.
- •PD-L1 combined positive score (CPS) less than 1 as determined by tissue testing.
- •At least one measurable lesion according to RECIST 1.1 criteria.
- •ECOG performance status 0-
- •Life expectancy >3 months.
- •Adequate organ and marrow function:
排除标准
- •1. Known HER2-positive expression (immunohistochemistry [IHC] 3+ or 2+ with a fluorescence in situ hybridization HER2:CEP17 ratio ≥2).
- •Presence of other malignancies within 5 years prior to treatment, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally treated prostate cancer, and ductal carcinoma in situ (hormone therapy for non-metastatic prostate cancer or breast cancer is permitted).
- •Known central nervous system metastases and/or carcinomatous meningitis.
- •Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction.
- •Hypertension that cannot be controlled with antihypertensive medications (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg).
- •History of bleeding within 4 weeks prior to screening, with any bleeding event graded as ≥3 according to CTCAE 5.
- •Thrombotic events (arterial or venous) within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (excluding previously thrombosed veins deemed healed by the investigator), and pulmonary embolism.
- •History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- •Patients who have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies at any time.
研究组 & 干预措施
Iparomlimab and Tuvonralimab combination with lenvatinib and SOX
Experimental
干预措施: Iparomlimab and Tuvonralimab combined with lenvatinib and SOX (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate
时间窗: Up to approximately 2 years
次要结局
- Major pathological response (MPR) rate(Up to approximately 2 years)
- R0 resection rate(Up to approximately 2 years)
- Objective response rate (ORR)(Up to approximately 2 years)
- Event-free survival (EFS)(Up to approximately 2 years)
- 12-month, 24-month, and 36-month event-free survival rates Disease-free survival (DFS)(Up to approximately 3 years)
- Overall survival (OS)(Up to approximately 5 years)
- 12-month, 24-month, and 36-month overall survival rates(Up to approximately 3 years)
研究者
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