Phase I, II study of neoadjuvant chemotherapy with gemcitabine and nab-paclitaxel for resectable pancreatic cancer - APCS-01

Ishido Keinosuke0 个研究点目标入组 30 人开始时间: 2020年5月8日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Pathologically adenocarcinoma or adenosquamous carcinoma is confirmed.
•2. No distant metastasis except for the positive case of intraoerative abdominal cytology.
•3. Resectable pancreatic cancer according to the Japan Classification of pancreatic cancer 7th edition.
•4. Patients who are tolerable for radical surgery,
•5. Patients who had not treated for pancreatic cancer.
•6. Over 20 y.o.
•7. ECOG PS, 0-1
•8. In cases with obstructive jaundice, proper drainage is performed.
•9. Cases in which functions of major organs (bone marrow, liver, kidney, lung, etc.) are retained.
•10. The informed consent has been obtained from the patient concerning the participation in the document.

•1. Patients who had treated with gemcitabine and nab-paclitaxel.
•2. Patients who are judged that R2 resection is anticipated.
•3. Severe diarrhea
•4. Patients who have sever ascitis fluid and pleural effusion.
•5. Patients who have active malignant disease but pancreatic cancer.
•6. Patients who have sever co-morbidity.
•7. Patients who have active infection except type B and C viral hepatitis.
•8. Patients who have either significant abnormality of ECG or sever heart disease.
•9. Patients who have sever psychiatric disease.
•10. Pregnant women, nursing women and cases who are likely to be pregnant or willing, men who wish to be pregnant by partner.
•11. Patients that have experienced severe drug allergies in the past
•12. Cases receiving continuous systemic administration of corticosteroids.
•13. Patients where administration of gemcitabine and nab-paclitaxel is contraindicated.
•14. Other cases that the doctor in charge judged unsuitable for safely carrying out this study.

发起方

Ishido Keinosuke