KCT0004421招募中未知
A phase 2 trial of Neoadjuvant modified FOLFIRINOX chemotherapy for resectable pancreatic adenocarcinoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 27
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
- •? Patient with pancreatic ductal adenocarcinoma diagnosed by histologic or cytopathological examination
- •(2) Patients with pancreatic adenocarcinoma who are determined as resectable according to the following criteria in imaging tests including CT or MRI (based on the NCCN guidelines, all of the following criteria should be met)
- •A. There is no tumor contact with the major arterial structures of the Celica axis [CA], superior mesenteric artery [SMA], common hepatic artery [CHA]
- •B. Superior mesenteric vein (SMV) or portal vein (PV) is not in contact with the tumor, or within 180 degree of contact, and has no abnormality in vein morphology.
- •? Patients without previous surgical resection and systemic chemotherapy for pancreatic cancer
- •? patients whose ECOG activity is 0 ~ 1
- •? Patients who are willing and able to write written consent of the subject.
- •? At the time of signature, the patient should be 19 years old or older.
- •? Patient with evaluable lesion according to RECIST 1.1.
- •? Patients with appropriate organ function (Table 1)
- •Table 1. Laboratory findings showing appropriate organ function.
- •Absolute neutrophil count (ANC) =1,500 / mcL
- •Platelets =100,000 / mcL
- •Hemoglobin =9 g / dL or =5.6 mmol / L (within 7 days before evaluation) without receiving hemoglobin transfusion or showing no EPO dependence
- •Serum creatinine or
- •Creatinine clearance measure or calculated value a (GFR may be used instead of creatinine or CrCl) = 1.5 X Normal upper limit (ULN) or =60 mL / min, creatinine level> 1.5 X Test subject ULN
- •Total bilirubin = 2.0 X ULN
- •AST (SGOT) and ALT (SGPT) 3 X ULN
- •Albumin> 2.5 mg / dL
- •Blood clotting
- •International Normalization Rate (INR) or Prothrombin Time (PT) =1.5 X ULN, unless the patient is receiving anticoagulant therapy and the PT or PTT is within the therapeutic range for the intended use of the anticoagulant.
- •Activated partial thromboplastin time (aPTT) =1.5 X ULN unless the patient is receiving anticoagulant therapy and the PT or PTT is within the therapeutic range for the intended use of the anticoagulant.
- •* Creatinine clearance should be calculated according to the standards of the laboratory.
- •? Appropriate liver function (endoscopic or percutaneous drainage as needed).
- •i. Total bilirubin = x 2 ULN.
- •ii. AST (SGOT) / ALT (SGPT) & lt; = x 3 ULN
- •? Patients who do not have active infection and are considered to be able to participate in the study considering the accompanying disease.
- •? Patients with appropriate bile duct drainage by PTBD or ERCP stenting in cases with obstructive jaundice.
- •? Patients who voluntarily agreed to participate in the study.
- •? The pregnant woman should agree to the use of appropriate contraceptive method and be negative pregnancy reaction in urine test or serum test.
排除标准
- •1. Other histologic diagnosis except for pancreatic ductal adenocarcinoma (eg neuroendocrine tumors)
- •2. Patients with distant metastasis or peritoneal metastasis including central nervous system (CNS) metastases
- •3. In patients with acute or chronic medical conditions or abnormal findings on the test that affect the results of this trial
- •4. Patients who have participated in the study in which the clinical trial drug is used and are currently receiving the clinical trial drug or who used the clinical trial drug or clinical test medical device within 4 weeks prior to the first administration date of the test drug.
- •5. Patients who have received chemotherapy, targeted small molecule, or radiotherapy within 2 weeks prior to the first day of this study, or who have not recovered from toxicity of prior therapy tio the grade 1 or baseline level.
- •6. Patients with other malignant tumors that require active treatment or whose progressing within the last 3 years. The exceptions are skin basal cell carcinoma, skin squamous cell carcinoma and thyroid cancer or cervical cancer, which have been treated for cure.
- •7. Patients with previous Grade 2 or higher peripheral neurotoxicity
- •8. Pregnant or breastfeeding women.
- •9. Patients who had previously received anticancer, radiation, or surgical treatment for pancreatic cancer
- •10. Patiens with illness, treatment, laboratory abnormalities causing confusion in clinical trial results, interfere with the patient's participation in the whole clinical trial, and making the clincial trial participation is not best choice for the patient, according to the investigator's decision
- •11. Patients with known mental illness or substance abuse disorder that may interfere with compliance with clinical trial requirements.
- •12. Patients with child bearing pan during scheduled clinical trials from screening visits to 120 days after the last dose of the test drug.
- •13. Patients with known history of human immunodeficiency virus (HIV) (HIV-1/2 antibody).
- •14. Patients who are known to have active hepatitis B (eg HBsAg positive and HBV DNA >=100 IU detected) or hepatitis C (anti-HCV positive and HCV RNA [qualitatively] detected)
- •15. Patients who received live vaccine within 30 days prior to the date of the first dose of this test.Note: Seasonal flu vaccines are usually inactivated flu vaccines; However, nasal administration of influenza vaccines (such as Flu-Mist®) is an active live infection of the whole body that is not attenuated because it is an attenuated live bacterial vaccine.
- •16. Patients with a history of hypersensitivity or serious adverse reactions to 5-FU, leucovorin, oxaliplatin, irinotecan.
- •17. Patients with contraindications to 5-FU, leucovorin, oxaliplatin, irinotecan.
研究者
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