KCT0004391招募中未知
A phase II clinical study of trastuzumab in combination with capecitabine and cisplatin (XP) in patients with tissue HER2-negative but serum HER2-positive advanced gastric cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •Inclusion criteria related to illness
- •1.Patients with inoperable, locally-advanced or recurrent and/or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are not eligible for curative therapy and are histologically diagnosed.
- •2.Diseases measurable according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) using imaging technique (CT or MRI).
- •3.Tissue HER2-negative tumors (primary or metastatic tumors) defined as IHC2+ and FISH- or IHC 0 or 1+ according to gastric cancer assessment system for HER2 (see Annex 12.5).
- •4.ECOG Performance status 0, 1 or 2 (see Annex 12.1).
- •5.Survival for at least 3 months should be possible.
- •6.Tissue HER2-negative but serum HER2-positive (Present a reference).
- •7.Appropriate bone marrow, renal, and hepatic functions.
- •General inclusion criteria
- •8.Males or females aged ? 19 years.
- •9.Patients should sign the informed consent form (ICF).
排除标准
- •Tumor-associated exclusion criteria
- •1.Patients who previously received chemotherapy for advanced/metastatic diseases (adjuvant/neoadjuvant chemotherapy, completed at least 6 months prior to enrollment in this clinical study, is permitted, but platinum-based adjuvant/neoadjuvant chemotherapy is not permitted).
- •2.Patients with a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome (e.g., patients who underwent partial or total gastric resection can participate in this clinical study, but patients equipped with a jejunostomy tube cannot participate).
- •3.Patients with active (serious or uncontrolled) gastrointestinal bleeding.
- •4.Patients with relevant toxicities remaining following previous curative therapy (except for alopecia). For example, neurotoxicity = grade 2 based on NCI-CTCAE version 5.0.
- •5.Patients with a history of other malignant diseases based on the date of complete recovery within 5 years prior to the initiation of treatment in this clinical study (except for in-situ cervical cancer and basal cell carcinoma).
- •Hematologic, blood chemistry, and organ functions
- •6.Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L.
- •7.Serum bilirubin> 1.5 × upper limit of normal (ULN); or AST or ALT > 2.5 × ULN (or > 5 × ULN hepatic metastasis patients); or alkaline phosphatase > 2.5 × ULN (or > 5 × ULN hepatic metastasis patients, or > 10 × ULN hepatic metastasis-free bone metastasis patients); or, albumin < 2.5 g/dL.
- •8.Creatinine clearance < 60 mL/min. However, creatinine clearance is first calculated using the Cockroft-Gault formula, and if the value is < 60ml/min, a 24hr urine collection test is carried out. Subject enrollment is possible only when creatinine clearance is = 60mL/min.
- •Other investigational product-associated exclusion criteria
- •9.History of proven congestive heart failure; angina pectoris in need of medication; evidence of transmural myocardial infarction through electrocardiogram (ECG); uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg); clinically significant heart valve disorders; and high-risk uncontrolled arrhythmia.
- •10.Baseline left ventricular ejection fraction (LVEF) < 50% (measured with echocardiogram or MUGA).
- •11.Patients with dyspnoea at rest due to advanced tumors or other diseases, or who need an adjuvant oxygen therapy.
- •12.Patients who are treated with long-term or high-dose corticosteroids (steroid inhalation or short-term use of oral steroids for vomiting inhibition and appetite stimulation is permitted).
- •13.Patients with Clinically significant hypoacusis
- •14.Patients known to show dihydropyrimidine dehydrogenase (DPD) deficiency.
- •General exclusion criteria
- •15. Patients with a history of brain metastasis or clinical evidence.
- •16.Uncontrolled serious systemic intercurrent diseases (e.g., infection or uncontrolled diabetes).
- •17.Females who are pregnant or are breast-feeding.
- •18.Fertile males and females who are unwilling to use effective contraceptive methods.
- •19.Patients who are treated with another investigational product within 4 weeks prior to the initiation of treatment in this clinical study.
- •20.Patients receiving radiation therapy within 4 weeks prior to the initiation of treatment with the study drug (palliative radiation curative therapy that is partially carried out for bone metastasis. Washout period of 2 weeks is also permitted in patien
研究者
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