NCT05318339招募中2 期
Open-label, Single-arm Phase II Study of Trastuzumab and Pyrotinib Combination Regimen in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma Refractory to Standard Therapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
A open-label, single-arm, phase II trial to study was designed to evaluate the effectiveness and safety of trastuzumab and pyrotinib in treating HER2 positive patients who have previously treated, locally advanced, or metastatic urothelial carcinoma.
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
- •Sign the informed consent form
- •Locally advanced or metastatic histologically confirmed transitional cell carcinoma of the urothelium, including the bladder, urethra, ureter, or renal pelvis
- •18 years and older
- •HER2 expression (3+ or 2+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization
- •Relapsed from or failed at least one prior standard systemic chemotherapy regimen, including immunotherapy, HER2 ADC durgs, and chemothearpy containing cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine
- •At least 1 measurable lesion could be evaluated by RECIST v1.1
- •Performance status: ECOG 0-1
- •Life expectancy more than 12 weeks
- •Ejection fraction at least 50% (or lower limit of normal) by echocardiogram
- •Good organ function:
- •Blood routine: hemoglobin ≥80g/L, neutrophil ≥1.5×10^9/L, platelet ≥75×10^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL, ALT≤5×UNL and AST≤5×UNL for patients with liver metastasis
排除标准
- •Have received trastuzumab or pyrotinib treatment in the past
- •Known to have allergic reactions to any ingredients or excipients of experimental drugs
- •Radiotherapy, RFA, interventional therapy or surgery were performed within 28 days before the first medication (except for previous diagnostic biopsy)
- •Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment
- •Clinically significant ascites
- •Brain metastasis or meningeal metastasis with neurological symptoms
- •Diabetes was not controlled, defined as HbA1c > 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure > 140 / 90 mmHg after antihypertensive drug
- •Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months
- •Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C
- •Pregnant or nursing
- •May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results
- •There are other serious diseases that the researchers believe patients cannot be included in the study
研究组 & 干预措施
Trastuzumab + Pyrotinib
Experimental
Patients receive a loading dose of trastuzumab IV over 90 minutes on day 1 of week 1. For all subsequent doses, patients receive trastuzumab IV over 30 minutes every three weeks.
Meanwhile, patients also receive pyrotinib 400mg PO daily. Treatment may continue till unacceptable toxicity or disease progression occurs.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
ORR
时间窗: 1 year
Objective response rate as assessed by RECIST criteria
次要结局
- OS(From date of initiation of treatment to date of death due to any cause, assessed up to 2 years)
- PFS(From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years)
研究者
Aiping Zhou
Vice director of Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Chinese Academy of Medical Sciences
研究点 (1)
Loading locations...
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