JPRN-jRCTs071190007进行中（未招募）2 期
A phase II clinical trial examining trastuzumab biosimilar (CT-P6) and chemotherapy (oxaliplatin +S-1 or oxaliplatin +Capecitabine) for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy - TROX Study
Oki Eiji0 个研究点目标入组 68 人开始时间: 2019年5月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)The individual consents in writing to receipt of the protocol treatment
- •2)A lead investigator deems that the patient can be treated with the protocol (the patient is suitable for enrollment)
- •3)The cancer is histopathologically confirmed (via resected surgical specimens biopsied tissue) to be a common type of gastric cancer (adenocarcinoma)
- •4)Up to 28 days prior to enrollment, contrast-enhanced CT scans of the trunk (chest,upper abdomen,and pelvis) confirm that 1 or more target lesions is present according to RECIST v1.1
- •5)The primary tumor or a metastatic focus is determined to be HER2-positive
- •6)The patient has not previously received chemotherapy, immunotherapy, or radiation therapy (except for local irradiation of bone metastases)
- •7)When a patient has advanced/recurrent gastric cancer not amenable to curative surgery
- •8)When a patient undergoes surgery for gastric cancer in the form of extensive surgery, standard surgery, or some other procedure, trial participation will be at least 2 weeks afterwards when postoperative complications have abated
- •9)The patient's age upon enrollment is over 20 years
- •10)The patient has a PS of 0 or 1 on the ECOG Scale
- •11)The patient is readily able to take medication orally
- •12)The patient is fully expected to survive for 3 months or longer from the day of enrollment
- •13)The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient's laboratory results from up to 14 days prior to enrollment fall within the criteria
- •i)WBC count<=12,000/mm3
- •ii)Neutrophil count>=1,500/mm3
- •iii)Platelet count>=100,000/mm3
- •iv)Hemoglobin>=8.0g/dL
- •v)Total bilirubin<=1.5mg/dL
- •vi) AST,ALT<=100IU/L
- •*200 IU/L or lower when liver metastasis is noted
- •vii)Albumin>=2.5g/dL
- •viii)Serum creatinine<=1.5mg/dL
- •ix)Creatinine clearance>=50mL/min1)The individual consents in writing to receipt of the protocol treatment
- •14) Left ventricular ejection fraction (LVEF) measured by echocardiography or cardiac scan multi-gating method (MUGA) within 14 days before registration is 50% or more
排除标准
- •1)A patient who has received a transfusion, blood product, or hematopoietic growth factor such as G-CSF up to 14 days prior to enrollment
- •2)The patient has severe drug hypersensitivity(particularly to platinum analogs, 5-FU, or S-1)
- •3)The patient has peripheral neuropathy affecting the sensory nerves(Grade 1 or worse)
- •4)The patient has an active infection
- •5)The patient has poorly controlled hypertension
- •6)The patient has poorly controlled diabetes(patients with controlled diabetes who are receiving insulin treatment are eligible for enrollment)
- •7) Significant electrocardiogram abnormality is recognized by 12 lead electrocardiogram within 14 days before registration, or the patient has heart disease that may pose a problem
- •8)The patient has severe pulmonary disease
- •9)he patient has a psychiatric disorder that may pose a problem or a history of central nervous system dysfunction
- •10)The patient has active gastrointestinal tract bleeding requiring repeated transfusions
- •11)The patient is receiving phenytoin, warfarin potassium,or flucytosine
- •12)The patient has moderate or more severe fluid accumulation in body cavities,such as pleural effusions and ascites,that continually requires treatment such as drainage
- •13)The patient has brain metastasis or clinical features suggesting brain metastasis
- •14)The patient has extensive bone metastasis(as determined by the patient's primary physician)
- •15)The patient has watery diarrhea(watery stool)(Grade 2 or worse)
- •16)The patient has active multiple cancers
- •17)The patient has a history of receiving platinum-based antineoplastic agents(e.g. oxaliplatin and cisplatin)
- •18)A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner
- •19)The patient tests positive for HBsAg or antibodies to HCV(Date of testing required)
- •20)A patient who is deemed to need antiviral therapyb(as of enrollment) for HBV-related hepatitis
- •21)A lead investigator or the patient's primary physician otherwise deems that participation in this trial is not appropriate for the patient
研究者
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