NCT07148427尚未招募2 期
A Single-arm, Phase II Clinical Study Protocol of Lparomlimab and Tuvonralimab in Combination With Regorafenib and Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
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
- 40
- 主要终点
- Objective response rate
研究概览
简要总结
A single-arm, Phase II clinical study protocol of Apatolimab Tovolimab in combination with regorafenib and chemotherapy as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in this study and has signed the informed consent form.
- •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
- •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.
- •8. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- •9. 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 regorafenib and chemotherapy
Experimental
干预措施: Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy (Drug)
结局指标
主要结局
Objective response rate
时间窗: Up to approximately 2 years
次要结局
- Progression-free survival (PFS)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)
- Duration of response (DoR)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 5 years)
- The incidence and severity of adverse events (AE) during the study period (Safety)(Up to approximately 2 years)
研究者
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