NCT03613168已完成2 期
The Pilot Study of Trastuzumab in Combination With Gemcitabine Plus Cisplatin for HER2-positive Biliary Tract Cancer
Changhoon Yoo1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年6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
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Trastuzumab is approved for the treatment of HER2-positive breast cancer and gastric cancer. The recent study showed that HER2 overexpression or amplification is noted about 5-15% of total biliary tract cancer patients. The aim of this study is to evaluate the efficacy and safety of trastuzumab in the combination of current standard gemcitabine plus cisplatin.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject with disease that is not amendable to a curative treatment approach or locally advanced or metastatic or unresectable CCC with histological diagnosis
- •At least one measurable(per RECIST 1.1) lesion
- •Primary or metastatic tumor with HER2 positive defined on IHC2+, FISH+ or IHC3+
- •ECOG Performance status 0 or 1
- •At least 3 months for life expectancy Common inclusion criteria
- •Men or women over 19 years at time of signing ICF
- •Signed Informed Consent Form
排除标准
- •Received prior chemotherapy for advanced/metastatic disease (the adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrolled will be accepted)
- •Not recovery from toxicities related to any prior treatments excluding alopecia (eg, neurological toxicity to ≥ Grade 2)
- •History of malignancy other than CCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death, such as carcinoma in situ or thyroid papillary carcinoma Hematology, chemistry or organ function
- •ANC < 1.5 × 109/L, or Platelet < 100 × 109/L
- •Total bilirubin > 1.5 × ULN; or AST/ ALT > 2.5 × ULN (or if the tumor has expanded into the liver, > 5 × ULN); or, alkaline phosphatase > 2.5 × ULN (or > 5 × if the tumor has expanded into the liver, or > 10 × ULN if the tumor has expanded into the brain without liver,); or albumin < 2.5 g/dL
- •Creatinine clearance < 60 mL/min(calculated using the Cockcroft-Gault formula) Other exclusion criteria related to IP
- •History of proved congestive heart failure; angina with medication; evidence of transmural myocardial infarction on ECG; uncontrolled hypertension(systolic> 180 mmHg or diastolic> 100 mmHg); clinically significant heart valve disease; uncontrolled arrhythmia
- •LVEF < 50% (calculated by cardiac sonography or MUGA)
- •Subject with rest dyspnea due to metastatic tumor or other disease or who needs oxygen therapy
- •Chronic or high-dose corticosteroid treatment
- •Clinically significant Hearing impairment Common exclusion criteria
- •History or evidence of CNS metastases
- •Interstitial pneumonia or pulmonary fibrosis with symptom and exact lesion on chest X-ray
- •Hearing loss
- •Uncontrolled significant systemic disease (eg, infection or uncontrolled DM)
- •Pregnant or lactating females
- •Sexually active fertile subjects without contraception
- •Treatment with other investigational therapy within 4 weeks prior to initiation of study treatment
- •Radiotherapy within 4 weeks prior to initiation of study treatment (the rest at least 2 weeks after palliative radiotherapy for bone metastasis and recovery from the effects of radiation will be accepted.)
- •Major surgery within 4 weeks prior to initiation of study treatment
- •History of HIV and active HBV or HCV
- •Previously identified allergy or hypersensitivity to components of the study treatment formulations
研究组 & 干预措施
Trastuzumab plus Gem/Cis
Experimental
Gemcitabine 1,000 mg/m2 Day 1 and Day 8, every 3 weeks Cisplatin 25 mg/m2 Day 1 and Day 8, every 3 weeks Trastuzumab, every 3 weeks, 8 mg/kg at first cycle then, 6 mg/kg
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Response rate
时间窗: 6 months
Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Adverse events
时间窗: 2 years
Adverse events graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03
次要结局
- Overall survival(2 years)
- Progression-free survival(2 years)
研究者
Changhoon Yoo
Assistant professor
Asan Medical Center
研究点 (1)
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