A phase I/II study of intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel in pancreatic cancer patients with peritoneal metastasis - A phase I/II study of intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel in pancreatic cancer patients with peritoneal metastasis

akai Yousuke0 个研究点目标入组 44 人开始时间: 2019年1月25日最近更新: 2023年10月17日

试验速览

暂无简介。

•1. Histologically or cytologically proven pancreatic adenocarcinoma
•2. No previous antitumor treatment other than surgery and adjuvant chemotherapy
•3. Peritoneal metastasis confirmed by diagnostic imaging, staging laparoscopy or laparotomy within 14 days before secondary registration
•4. Adequate organ functions(according to the laboratory data which was taken within 7 days before primary registration)
•5. Eastern Cooperative Oncology Group performance status 0-1
•6. Aged 20<=, 75> years old
•7. Oral intake
•8. Written informed consent

•1. Contraindication for gemcitabine, nab-paclitaxel or paclitaxel
•2. Other active concomitant malignancies at primary registration
•3. Allergy to iodine or gadolinium contrast agent
•4. Blood transfusion or use of G-CSF within 7 days beforeprimary registration
•5. Past or current severe heart disease, liver cirrhosis, active GI ulcers or obstruction
•6. Severe complications such as interstitial pneumonitis, pulmonary fibrosis
•7. Uncontrollable diabetes mellitus
•8. Grade 3/4 of sensory neuropathy
•9. Active infection rather than HBV/HCV
•10.Clinically apparent mental or central nerve disorders
•11. Pregnant or nursing women
•12. Judged to be unfit to participate in this study by investigators

发起方

akai Yousuke