2024-516318-40-02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
Rigshospitalet, Frederiksberg Hospital4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年11月29日最近更新:
适应症
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
- 4
- 主要终点
- If response in 12 out of 24 patients, the alternative hypothesis is accepted, and the drug is considered appropriate for further evaluation.
研究概览
简要总结
To determine the efficacy of trastuzumab added to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab) in patients with ESCC determined by 6 months progression free survival (PFS) (RECIST 1.1).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 either: a. IHC1+ and ISH positive (amplification ratio (HER2/CEP17) ≥ 2.0) and a high gene count fulfilling either: (HER2/cell) ≥ 6.0 or (HER2/cell) ≥ 4.0 assessed by two different ISH probes b. IHC2+ and ISH positive (ISH amplification ratio (HER2/CEP17) ≥ 2.0) c. IHC3+
- •Baseline left ventricular ejection fraction > 50% measured by echocardiography or MUGA
- •Adequate bone marrow function and organ function: a. Leucocytes > 3.0 x 109/l, neutrocytes > 1.5 x 109/l and thrombocytes > 100 x 109/l b. Serum bilirubin < 1.5 × upper limit of normal (ULN); and AST/ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases). c. 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
- •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
- •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.
结局指标
主要结局
If response in 12 out of 24 patients, the alternative hypothesis is accepted, and the drug is considered appropriate for further evaluation.
If response in 12 out of 24 patients, the alternative hypothesis is accepted, and the drug is considered appropriate for further evaluation.
次要结局
未报告次要终点
研究者
Paul Morten Mau-Sørensen
Scientific
Rigshospitalet
研究点 (4)
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