KCT0009625尚未招募Unknown
An open-label, phase II study of steroid pulse as a neoadjuvant therapy for locally advanced or intrathoracic metastatic thymoma
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 21
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
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •? A patient who is 19 years of age or older and 75 years of age or younger to understand the purpose of the clinical trial and the written consent form at the time of obtaining the consent form.
- •? A patient who was newly confirmed histologically with thymoma and had no previous treatment history for thymoma.
- •? ? ECOG Performance Status 0 1
- •? Where it is determined that surgical resection is possible by a cardiothoracic surgeon and one or more of the following is satisfied.
- •1) thymoma of 7cm or more in long diameter
- •2) locally progressive thymoma invading the surrounding organs of the thoracic cavity
- •3) diseases confined to the thoracic cavity, such as pleural metastases.
- •? A patient who is willing and adaptable to the test plan during the trial period
- •? HBsAg (+) can be registered if the researcher is taking appropriate prophylactic antiviral drugs or scheduled
- •? Patients with appropriate major organ functions identified by blood tests conducted within 28 days of trial treatment
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L
- •- Platelet count = = 75,000/µL
- •- hemoglobin = 9 g/dL
- •- 1.5x serum creatinine = normal upper limit (ULN)
- •- - AST(SGOT) ALT (SGPT) = 3.0 × ULN
- •- Total bilirubin = 2.0 x ULN
- •- - Alkaline phosphatase = 3.0 x
排除标准
- •? thymic carcinoma
- •? a thymoma patient with distant metastasis outside the thoracic cavity
- •? Patients who need extra steroid therapy due to severe work history
- •? Patients who are expected to have difficulty administering steroid pulses
- •- an uncontrolled overt infection
- •- uncontrolled glaucoma
- •- Uncontrolled diabetes (HbA1c = 9.0)
- •- uncontrolled heart failure
- •? Subjects during pregnancy or lactation, or women planning to become pregnant during clinical trials
- •? Patients who are not suitable for radical surgery and general anesthesia in the judgment of the researcher
- •? All women eligible for pregnancy must have a negative pregnancy test (serum or urine) result taken within 7 days prior to the first dose of the clinical trial drug (considered menopause if it is amenorrhea for more than 12 months).
- •? Other subjects that are not appropriate for the researcher to judge
研究者
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