A Phase III, Open-label, Randomized Study of the Combination Therapy with NC-6004 and Gemcitabine versus Gemcitabine Alone in Patients with Locally Advanced or Metastatic Pancreatic Cancer

anoCarrier Co., Ltd.0 个研究点目标入组 310 人开始时间: 2017年6月20日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Male or female aged between 20 to 80 years
•2) Unresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer
•3) Presence of at least one measurable tumor lesion
•4) No prior systemic anti-cancer therapy and radiotherapy for advanced pancreatic cancer
•5) Eastern Cooperative Oncology Group performance status of <= 1
•6) Adequate organ function
•7) If fertile, willing to use barrier contraception till 6 months after the end of treatment
•8) Willing and able to comply with study procedures and provide written informed consent

•1) Pregnancy or breastfeeding
•2) Active concomitant malignancy or history of other cancer
•3) Metastasis to the central nervous system or brain
•4) Evidence of hearing impaired >= Grade 2
•5) Patient with pulmonary fibrosis or interstitial pneumonia
•6) Marked pleural effusion or ascites above Grade 2
•7) Patient with known HIV infection
•8) Patient with active hepatitis B, hepatitis C or any other ongoing severe infections
•9) Patient with severe mental disorder
•10) As judged by the investigator, any evidence of significant laboratory findings or severe/uncontrolled clinical disorders
•11) Patient with known hypersensitivity to Pt compounds
•12) Known severe drug hypersensitivity
•13) Treatment with a non-approved or investigational product within 30 days before Day 1 of study treatment
•14) Alcoholic liver disease or liver disease with obvious clinical symptom or sign
•15) Daily Alcohol consumption within 6 months before the screening
•16) Patient with uncontrolled diabetes
•17) Radiotherapy within 6 months before screening
•18) Experienced Abdominal Radiotherapy
•19) Experienced treatment of Gemtuzumab ozogamicin
•20) Patient with autoimmune hepatitis or idiopathic thrombocytopenic purpura
•21) Observation of attenuated or reversed hepatic venous portal blood flow was confirmed by doppler ultrasonography or CT of the liver

发起方

anoCarrier Co., Ltd.