KCT0008255尚未招募Unknown
A Phase I Study to Assess the Safety of adjuvant Natural killer cell inj. in Combination with Standard Treatment in Patients with radical pancreatectomy
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 3
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 o Limit（—）
- 性别
- All
入选标准
- •1) Patients with histologically or cytologically confirmed pancreatic adenocarcinoma after undergoing radical resection
- •2) Pathologically confirmed stage 1 to 3 patients based on AJCC 8th edition
- •3) Age 19 or older
- •4) Ability to perform daily activities -Patients with ECOG (Eastern Cooperative Oncology Group) scale = 2
- •5) Patients with adequate bone marrow function
- •? Absolute Neutrophil Count = 1,500/?
- •? Hemoglobin = 8.0g/dL
- •? Platelet Count = 100,000/?)
- •6) Patients with adequate liver and renal function
- •? Total bilirubin = 1.5 X ULN
- •? AST/ALT <2.5?ULN, ALP <5?ULN (However, AST/ALT <5?ULN with liver metastases)
- •? Normal renal function (serum creatinine = 2 times the normal value)
- •7) A person who has written consent from the patient or legal representative
- •8) Female is a patient who was negative in a urine or blood pregnancy test 7 days before the first administration of clinical research drug and agreed to use appropriate contraception during the study period
排除标准
- •1) Patients who have not recovered from serious complications of pancreatectomy
- •2) Patients with distant metastasis or who underwent symptomatic resection when curative resection was not possible
- •3) Evidence of metastatic disease (including presence of tumor cells in ascites)
- •4) Past chemotherapy or radiotherapy for currently treated pancreatic cancer
- •5) Patients with a history of cancer other than pancreatic cancer within 3 years
- •6) Those who participated in other clinical studies within 4 weeks before the start of study drug administration in this study
- •7) Pregnant and lactating women
- •8) Active viral infection (However, if you are a carrier of hepatitis B, you can register if the HBV DNA titer is 20,000 IU/mL or less, and antiviral agents for hepatitis B can be used prophylactically according to the doctor's judgment)
- •9) Active HIV infection
- •10) Actively infected persons with serious bacterial, viral, or fungal infections or requiring systemic medical treatment
- •11) Those who are judged unsuitable for clinical research due to accompanying serious medical or psychiatric diseases
- •12) Those with severe heart disease (myocardial infarction/angina pectoris/severe arrhythmia/congestive heart failure)
- •13) Patients currently being treated for autoimmune diseases (lupus erythematosus/rheumatoid arthritis/myasthenia gravis)
- •14) Patients who have taken immunosuppressive drugs including steroids within 4 weeks (However, topical steroids, inhaled steroids, and low-dose oral steroids (prednisone 10mg/day or less) are permitted.)
研究者
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