KCT0009511招募中Unknown
A Study to Evaluate the Safety and Efficacy of CLZ-3002, Concomitantly Treated with Concurrent Chemoradiation Therapy (CCRT), in Patients Newly diagnosed with Glioblastoma
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1) Patients who voluntarily decided to participate and gave written consent after hearing about the characteristics of this clinical trial and clinical trial drugs
- •2) Adults between the ages of 19 and 70
- •3) As a glioblastoma patient,
- •? Diagnosed as glioblastoma confined to the supratentorial compartment in imaging diagnosis,
- •? Glioblastoma (IDH-wild type) confirmed at the time of surgery or by histological examination afterward
- •4) Those who scored 2 points or less on ECOG
- •5) Those who are scheduled to undergo radiation and temozolomide combination therapy (CCRT) after tumor removal surgery
排除标准
- •1) Recurrent glioblastoma
- •2) Leptomeningeal dissemination and other distant metastasis (bone marrow, lung, liver, etc.) glioblastoma
- •3) When only tumor tissue biopsy was performed
- •4) Applicants of Gliadel wafer or local brachytherapy
- •5) Those who cannot perform MRI according to the clinical trial schedule
- •6) If toxicity of previous treatment has not recovered to baseline level or CTCAE Grade 1 or lower, except for alopecia
- •7) Past or current medical history of newly diagnosed cardiovascular disease within 3 months prior to participation in this clinical trial that is not controlled by the following
- •(1) congestive heart failure
- •(2) myocardial infarction
- •(3) Unstable angina with new drug administration or dose change within 3 months
- •(4) Arrhythmias with pacemaker implantation
- •(5) Transient ischemic attack (TIA) or stroke with neurologic deficits
- •8) Severe renal impairment (CrCl <30mL/min), renal failure, patients undergoing renal dialysis, etc.)
- •9) History of severe hepatic impairment (liver cirrhosis) or abnormality in laboratory tests corresponding to the following (retest before administration of ‘human cells, etc.’ is possible)
- •(1) ALT more than 3 times the upper limit of normal (UNL); More than 5 times in patients with liver metastases
- •(2) Total bilirubin more than 1.5 times the upper limit of normal (UNL); More than 3 times in case of Gilbert syndrome.
- •10) Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) that is not controlled by anticoagulant treatment, etc.
- •11) Patients with diabetes not controlled by oral hypoglycemic agents or insulin
- •12) Immunodeficiency requiring immunoglobulin or immunostimulant treatment
- •13) Past and current history of chronic autoimmune disease (However, type 1 diabetes and hypothyroidism are not applicable.)
- •14) Abnormalities in the following test values (can be retested until peripheral blood collection)
- •(1) Hgb<9 g/dL
- •(2) Absolute neutrophil count (ANC) <1,500 cells/mm³
- •(3) Platelet count <100,000 cells/mm³
- •15) A history of malignant tumors that occurred within 3 years other than the indications for this clinical trial. However, thyroid cancer (stage I or II papillary, follicular, medullary types), basal cell or squamous cell carcinoma of the skin, CIN and CIS of the cervix, and intraepithelial carcinoma of other sites are excluded.
- •16) Patients with the following clinically active infections
- •(1) Hepatitis B (if confirmed positive in HBsAg test, HBV nucleic acid amplification test)
- •(2) Hepatitis C (if confirmed positive by HCV antibody test or HCV nucleic acid amplification test)
- •(3) HIV infection (HIV antibody test, HIV nucleic acid amplification test positive)
- •(4) Syphilis infection (if non-treponemal test or treponema test positive)
- •(5) Other active infection or unexplained fever >38.5°C (101.3°F) judged unlikely to participate in the clinical trial.
- •17) Previous history of hypersensitivity to the ingredients constituting this clinical trial drug (CLZ-3002 active ingredient and excipient)
- •18) The following contraindications to Temozolomide.
- •(1) Previous history of hypersensitivity to temozolomide or dacarbazine
- •(2) galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •19) Diclofenac acid Contraindications
- •20) Subjects who received contraindicated medicines or treatments before participating in clinical trials and for whom the specified period has not elapsed
- •21) Patients scheduled to receive concomitantly contraindicat
研究者
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