KCT0003158尚未招募未知
A pilot study of trastuzumab in combination with gemcitabine plus cisplatin in patients with advanced biliary tract cancer
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 15
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 o Limit（—）
- 性别
- All
入选标准
- •Inclusion criteria related to disease
- •1.The subject with disease that is not amendable to a curative treatment approach or locally advanced or metastatic or unresectable CCC(Cholangiocarcinoma) with histological diagnosis
- •2.At least one measurable(per RECIST 1.1) lesion
- •3.Primary or metastatic tumor with HER2 positive defined on IHC2+, FISH+ or IHC3+
- •4.ECOG Performance status 0 or 1
- •5.At least 3 months for life expectancy
- •Common inclusion criteria
- •6.Men or women over 19 years at time of signing ICF(Informed Consent Form)
- •7.Signed Informed Consent Form
排除标准
- •Exclusion criteria related to tumor
- •8.Received prior chemotherapy for advanced/metastatic disease (the adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrolled will be accepted)
- •9.Not recovery from toxicities related to any prior treatments excluding alopecia (eg, neurological toxicity to = Grade 2)
- •10.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
- •11.ANC < 1.5 × 109/L, or Platelet < 100 × 109/L
- •12.Total bilirubin > 1.5 × ULN; or AST/ ALT > 2.5 × ULN (Upper Limit of Normal 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
- •13.Creatinine clearance < 60 mL/min(calculated using the Cockcroft-Gault formula)
- •Other exclusion criteria related to IP(Investigational Product)
- •14.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
- •15.LVEF(Left Ventricular Ejection Fraction) < 50% (calculated by cardiac sonography or MUGA(MUltiGAted acquisition)
- •16.Subject with rest dyspnea due to metastatic tumor or other disease or who needs oxygen therapy
- •17.Chronic or high-dose corticosteroid treatment
- •18.Clinically significant Hearing impairment
- •Common exclusion criteria
- •19.History or evidence of CNS(Central Nervous System) metastases
- •20.Interstitial pneumonia or pulmonary fibrosis with symptom and exact lesion on chest X-ray
- •21.Hearing loss
- •22.Uncontrolled significant systemic disease (eg, infection or uncontrolled DM-Diabetes Mellitus)
- •23.Pregnant or lactating females
- •24.Sexually active fertile subjects without contraception
- •25.Treatment with other investigational therapy within 4 weeks prior to initiation of study treatment
- •26.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.)
- •27.Major surgery within 4 weeks prior to initiation of study treatment
- •28.History of HIV((human immunodeficiency virus) and active HBV(Hepatitis B virus) or HCV(Hepatitis C virus)
- •29.Previously identified allergy or hypersensitivity to components of the study treatment formulations
研究者
相似试验
进行中（未招募）
1 期
A study in HER2-positive breast cancer that has spread to other organs or tissues and has not responded to a course of anti-cancer treatment and a study in HER2-positive inoperable gastric cancer or gastric cancer that has spread to other organs or tissues.HER2-positive metastatic breast cancer and HER2-positive locally advanced or metastatic gastric cancer.MedDRA version: 19.0Level: PTClassification code 10066896Term: HER-2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-001547-46-DEF. Hoffmann-La Roche Ltd.160
进行中（未招募）
1 期
A study in HER2-positive breast cancer that has spread and has not responded to a course of anti-cancer treatment and a study in HER2-positive gastric cancer that has spread and has not been treated with any chemotherapeutic agent before.HER2-positive metastatic breast cancer and HER2-positive locally advanced or metastatic gastric cancer.MedDRA version: 17.1Level: PTClassification code 10066896Term: HER-2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-001547-46-GRF. Hoffmann-La Roche Ltd.235
进行中（未招募）
1 期
A study in HER2-positive breast cancer that has spread to other organs or tissues and has not responded to a course of anti-cancer treatment and a study in HER2-positive inoperable gastric cancer or gastric cancer that has spread to other organs or tissues.HER2-positive metastatic breast cancer and HER2-positive locally advanced or metastatic gastric cancer.MedDRA version: 20.0Level: PTClassification code 10066896Term: HER-2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-001547-46-PTF. Hoffmann-La Roche Ltd.160
进行中（未招募）
1 期
Phase I study of the combination of trastuzumab emtansine (T-DM1) and capecitabine in HER2-positive metastatic breast cancer and HER2-positive locally advanced/metastatic gastric cancer patients, followed by a randomized, open-label phase II study of trastuzumab emtansine and capecitabine versus trastuzumab emtansine alone in HER2-positive metastatic breast cancerEUCTR2012-001547-46-ITF. Hoffmann-La Roche Ltd.179
进行中（未招募）
1 期
A study in HER2-positive breast cancer that has spread and has not responded to a course of anti-cancer treatment and a study in HER2-positive gastric cancer that has spread and has not been treated with any chemotherapeutic agent before.EUCTR2012-001547-46-SKF. Hoffmann-La Roche Ltd.235