NCT05115500尚未招募2 期
Antibody-Drug Conjugate Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment Advanced Refractory Solid Tumors With HER-2 Positive(PRaG3.0)
Second Affiliated Hospital of Soochow University19 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 19
- 主要终点
- Objective Response Rate （ORR）
研究概览
简要总结
This is an open-label, single-arm, Phase II investigator-initiated trial of antibody-drug conjugate combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory solid tumors with HER-2 positive
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
- •Aged 18 years and above;
- •Diagnosed with histologically or cytologically-confirmed, HER2-positive(IHC 1+, 2+ or 3+), standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy;
- •ECOG(Eastern Cooperative Oncology Group) performance is 0-3;
- •Life expectancy greater than 3 months;
- •T lymphocyte absolute value ≥0.5 upper limit of normal (ULN), absolute neutrophil count(ANC)≥1.0 x 10(9)/L；serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0*ULN, or AST and ALT≤5*ULN with hepatic metastasis; Total serum creatinine ≤1.5*ULN；
- •Signed informed consent form；
排除标准
- •Current pregnancy or lactation；
- •History of other malignant tumors within 5 years prior to dose administration, expect for：malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer);
- •Uncontrolled epilepsy, central nervous system diseases or mental illness;
- •Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study;
- •Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- •Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes;
- •Allergic to any of the ingredients used in the study;
- •A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy;
- •Acute and chronic tuberculosis infection;
- •Other disorders with clinical significance according to the researcher's judgment.
研究组 & 干预措施
ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2
Experimental
干预措施: ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 (Drug)
结局指标
主要结局
Objective Response Rate （ORR）
时间窗: 24 months
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
次要结局
- Disease control rate (DCR)(24 months)
- Overall survival (OS)(24 months)
- Adverse event(24 months)
- Progression-free Survival (PFS)(24 months)
研究者
研究点 (19)
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