NCT05170256招募中2 期
HERES Trial: Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients
Morten Mau-Sørensen2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年2月4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
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS) .
研究概览
简要总结
The study aims to determine the efficacy of trastuzumab added to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab) in patients with HER2 positive Esophageal squamous cell carcinoma (ESCC) determined by 6 months progression free survival (PFS) (RECIST 1.1).
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
- •Signed informed consent
- •Age ≥18 years
- •Inoperable locally advanced or metastatic squamous cell carcinoma of the esophagus not amenable for curative intended therapy
- •HER2 positive defined as IHC2+ and FISH amplification ratio ≥2 or IHC3+
- •ECOG PS <2
- •Baseline left ventricular ejection fraction > 50% measured by echocardiography or MUGA
- •Adequate bone marrow function and organ function:
- •Hematopoietic function:
- •Leucocytes > 3.0 x 109/l, neutrocytes > 1.5 x 109/l and thrombocytes > 100 x 109/l
- •Serum bilirubin < 1.5 × upper limit of normal (ULN); and AST/ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases).
- •Creatinine clearance > 30 ml/min
排除标准
- •Prior systemic treatment with non-curative intent including HER2-targeting drugs. Prior neoadjuvant and adjuvant therapies as well as palliative radiotherapy are allowed
- •Significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate study treatment
- •Congestive heart failure (New York Heart Association (NYHA) class 3+4); uncontrolled angina pectoris; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); or high-risk uncontrollable arrhythmias.
- •Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
- •Patients with known hypersensitivity to trastuzumab or any of the study drugs, murine proteins, or to any of the excipients
- •Symptomatic brain metastases uncontrolled by corticosteroids or carcinomatous meningitis
- •Homozygosity or compound heterozygosity for more than one gene variant of dihydropyrimidine dehydrogenase (DPD) known to cause major reduced metabolism of 5-FU derivates OR plasma uracil > 150 ng/ml are not eligible. Patients with minor DPD insufficiency are allowed provided that local guidelines for administration of 5-FU are followed.
- •Any other cancer (excluding low risk prostate cancer, carcinoma in situ and radically operated localised squamous skin cancer) with clinical activity within the last 2 years
- •Other current cancer treatments except for anti-hormone and anti-resorptive treatment of bone metastasis.
- •Allopurinol, phenytoin, warfarin treatment is not allowed. Non vitamin K oral anticoagulants (NOAK) and low molecular weight (LMW) heparin is allowed
- •Pregnancy or breast-feeding
- •Positive serum pregnancy test in women of childbearing potential.
- •Subjects with reproductive potential not willing to use an effective method of contraception under and 3 months after participation in this study
研究组 & 干预措施
Treatment arm
Experimental
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Progression free survival (PFS) .
时间窗: 6 months
PFS according to RECIST 1.1
次要结局
- Overall survival(6 months)
- Response rate according to RECIST 1.1(Best response during 6 months follow-up)
- Frequency of AEs assessed by NCI CTCAE, v. 5.0(During minimum 6 months follow-up)
研究者
Morten Mau-Sørensen
MD PhD
Rigshospitalet, Denmark
研究点 (2)
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