JPRN-jRCTs051180104已完成2 期
Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with borderline resectable pancreatic cancer. - NAC-GA Trial
Yamaue Hiroki0 个研究点目标入组 62 人开始时间: 2019年3月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
研究概览
简要总结
This trial treatment, in which surgical resection is performed after two courses of GEM+nab-Paclitaxel as neoadjuvant chemotherapy, is effective. Careful management such as hospitalization is necessary for patients with pulmonary diseases.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1. Primary tumor is confirmed to be pancreatic cancer from histology, cytology, or imaging study and cases matching borderline resectable-arterial (BR-A), borderline resectable- venous (BR-PV) according to NCCN guidelines(Version 2.2016)
- •2. Measurable lesions
- •3. No previous treatment
- •4. ECOG Performance status 0 or 1
- •5. Age 20-80 years
- •6. Main organs functions meet the following criteria (latest value within 14 days before registration). Leukocytes <= 12,000/mm3, Neutrophil >= 1,500/mm3, Hemoglobin >= 9.0 g/dL, Platelets >= 100,000/mm3, Total bilirubin < 2.0 mg/dL (<= 3.0 mg/dl in biliary drainage case), Serum creatinine <= 1.5 mg/dL, AST/ALT < 2.5 x ULN.
- •7. Signed and dated informed consent before enrolment.
排除标准
- •1. Severe drug hypersensitivity or drug allergy
- •2. History of malignant tumors (*including that without recurrence in the past five years, intramucosal carcinoma requiring endoscopic curative resection, uterine cervical carcinoma requiring curative resection, basal cell carcinoma of the skin or Squamous cell carcinoma)
- •3. Active infectious disease
- •4. Peripheral sensory neuropathy (>= Grade 2)
- •5. Interstitial pneumonia or pulmonary fibrosis
- •6. Uncontrollable pleural effusion or ascites
- •7. Uncontrollable diabetes mellitus
- •8. Uncontrollable congestive heart failure, angina, hypertension, arrhythmia
- •9. Severe neurological/psychological symptoms
- •10. Diarrhea (Increase in fecal frequency and watery diarrhea)
- •11. Breast-feeding or pregnant / possibly pregnant, or women who do not agree to prevent conception, and both men and women without intention to use contraception during the period of the study and for a period of time (180 days) after the final administration of the investigational drug.
- •12. Additional cases the doctor deems inappropriate for the participation of the clinical trial
- •13. Meets the resectability status (resectable/unresectable) of NCCN guidelines (Version 2.2016) by the degree of progression according to MDCT.
- •14. Active hepatitis B
研究者
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