A Study of Nimotuzumab Combinated With Gemcitabine in K-RAS Wild-type Locally Advanced and Metastatic Pancreatic Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

November 30, 2021

Study Completion Date

November 30, 2021

Conditions
Pancreatic Cancer
Interventions
DRUG

nimotuzumab

nimotuzumab,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.

DRUG

Gemcitabine

Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test.

OTHER

Placebo

Placebo,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Trial Locations (25)

100005

Beijing Union Medical College Hospital, Beijing

100021

Chinese Academy of Medical Sciences Cancer Hospital, Beijing

100039

PLA General Hospital (301 Hospital), Beijing

100071

Affiliated Hospital of Military Medical Sciences, Beijing

100142

Beijing Cancer Hospital, Beijing

116027

Second Affiliated Hospital of Dalian Medical University, Dalian

150040

Cancer Hospital of Harbin Medical University, Harbin

200025

Shanghai Jiaotong University Affiliated Ruijin Hospital, Shanghai

200032

Shanghai Fudan University Cancer Hospital, Shanghai

Shanghai Zhongshan Hospital, Fudan University, Shanghai

200040

Shanghai Huashan Hospital, Fudan University, Shanghai

200080

First People's Hospital Cancer Center, Shanghai Jiaotong University, Shanghai

200433

Shanghai Changhai Hospital, Shanghai

210009

Jiangsu Province Tumor Hospital, Nanjing

214400

Jiangyin City People's Hospital, Jiangyin

230601

Second Affiliated Hospital of Anhui Medical University, Hefei

233004

First Affiliated Hospital of Bengbu Medical College, Bengbu

310003

First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

310009

Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

310016

Sir Run Run Shaw Hospital, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

350000

Fuzhou General Hospital of Nanjing Military Region, Fuzhou

350014

Fujian Provincial Tumor Hospital, Fuzhou

610083

General Hospital of Chengdu Military Region, Chengdu

710032

Affiliated Xijing Hospital, Fourth Military Medical University, Xi’an

All Listed Sponsors
collaborator

NanJing PLA 81 Hospital

OTHER

collaborator

Fudan University

OTHER

lead

Biotech Pharmaceutical Co., Ltd.

OTHER