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

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
nimotuzumab
Gemcitabine
Placebo
Sponsored by
Biotech Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age:18-75 years old
  • KPS≥60
  • Histological or cytological diagnosis that are unsuitable for radical radiotherapy or surgical treatment of locally advanced or metastatic pancreatic adenocarcinoma (≥6 months to the last adjuvant chemotherapy)
  • Has at least one objective measurable lesion can be evaluated according to Response Evaluation Criteria in Solid Tumors1.1(Helical CT examination of the longest diameter of target lesions≥10mm, such as lymph node metastasis only need the shortest path ≥15mm)
  • Life expectancy ≥12 weeks
  • K-RAS tumor tissue detected as the wild-type
  • Aspartate transaminase（AST）/aminotransferase（ALT）≤2.5×ULN，AST /ALT≤5×ULN（if liver metastases）；Total bilirubin≤2×ULN，Total bilirubin≤3×ULN（if liver metastases）；Absolute neutrophil count≥1.5×109/L；Blood platelet≥100×109/L；Hemoglobin≥90 g/L；Creatinine clearance≥60ml/min
  • Volunteered to participate this study, written informed consent and has a good compliance
  • Patients of childbearing age and their spouses are willing to take contraceptive measures

Exclusion Criteria:

  • Before this study had received the following treatments：As a means of anti-tumor palliative chemotherapy and molecular targeted therapy.Target lesion had received radiotherapy without progression.within 4 weeks or be participating in clinical trials of other therapeutic/ interventionist clinical trial.
  • Undergone major surgery within 4 weeks.
  • The brain metastasis or leptomeningeal metastasis.
  • Has a history of malignancy other than the pancreatic cancer (except for the cured cervix in situ or basal cell carcinoma, and a five-year cure other cancers).
  • The merger has symptoms of ascites and requires clinical treatment. Accompanied by other serious disease, including but not limited:Congestive heart failure which is difficult to control (NYHA III or IV), Unstable angina, Poorly controlled arrhythmia, Uncontrolled moderate to severe hypertension(systolic blood pressure（SBP）>160 mm Hg or diastolic blood pressure（DBP）>100 mm Hg).Active infection.Diabetes which is difficult to control.Has mental illness which impacts the informed consent and / or compliance program.HIV infection.There is serious illness that other researchers consider is unsuitable to participate this study.
  • Known allergy to anti-EGFR antibody formulations.

Sites / Locations

  • First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • Second Affiliated Hospital of Anhui Medical UniversityRecruiting
  • Beijing Union Medical College Hospital
  • Chinese Academy of Medical Sciences Cancer Hospital
  • PLA General Hospital (301 Hospital)Recruiting
  • Affiliated Hospital of Military Medical SciencesRecruiting
  • Beijing Cancer Hospital
  • Fuzhou General Hospital of Nanjing Military Region
  • Fujian Provincial Tumor Hospital
  • Cancer Hospital of Harbin Medical University
  • Jiangyin City People's Hospital
  • Jiangsu Province Tumor HospitalRecruiting
  • Second Affiliated Hospital of Dalian Medical UniversityRecruiting
  • Shanghai Jiaotong University Affiliated Ruijin Hospital
  • Shanghai Fudan University Cancer Hospital
  • Shanghai Zhongshan Hospital, Fudan UniversityRecruiting
  • Shanghai Huashan Hospital, Fudan UniversityRecruiting
  • First People's Hospital Cancer Center, Shanghai Jiaotong UniversityRecruiting
  • Shanghai Changhai Hospital
  • Affiliated Xijing Hospital, Fourth Military Medical UniversityRecruiting
  • General Hospital of Chengdu Military Region
  • First Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Sir Run Run Shaw Hospital
  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nimotuzumab and Gemcitabine

Placebo and Gemcitabine

Arm Description

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

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

Outcomes

Primary Outcome Measures

overall survival（OS）

Secondary Outcome Measures

Time to Progression（TTP）
Progression Free Survival（PFS）
Objective Response Rate（ORR）
Appeared efficacy from the beginning until proven disease progression
Disease Control Rate（DCR）
The number of cases in remission after being treated and the disease stabilized accounts the total percentage of the number of evaluable patients
Clinical Benefit Response（CBR）
Only evaluated the symptomatic patients in the study
To determine the safety of the treatment with Nimotuzumab and Gemcitabine (NCI Common Terminology Criteria for Adverse Events v4.03)

Full Information

First Posted
January 17, 2015
Last Updated
July 31, 2015
Sponsor
Biotech Pharmaceutical Co., Ltd.
Collaborators
NanJing PLA 81 Hospital, Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02395016
Brief Title
A Study of Nimotuzumab Combinated With Gemcitabine in K-RAS Wild-type Locally Advanced and Metastatic Pancreatic Cancer
Official Title
A Prospective, Randomized, Controlled, Double-blind, Multi-center Clinical Study of Nimotuzumab Combinated With Gemcitabine Contrast to Placebo Combinated With Gemcitabine in K-RAS Wild-type,Locally Advanced and Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.
Collaborators
NanJing PLA 81 Hospital, Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries.The clinical phase Ⅲ trial designed to assess overall survival（OS）of the combination of Nimotuzumab administered concurrently with Gemcitabine in patients with RAS wild type of locally advanced or metastatic pancreatic cancer
Detailed Description
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries.The clinical phase Ⅲ trial designed to assess overall survival（OS）of the combination of Nimotuzumab administered concurrently with Gemcitabine in patients with RAS wild type of locally advanced or metastatic pancreatic cancer.Secondary objectives include time to progression（TTP）,progression-free survival（PFS）,Objective Response Rate（ORR）,Disease Control Rate（DCR）,Clinical Benefit Response（CBR）and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab and Gemcitabine
Arm Type
Experimental
Arm Description
nimotuzumab,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. 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.
Arm Title
Placebo and Gemcitabine
Arm Type
Placebo Comparator
Arm Description
placebo,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. 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.
Intervention Type
Drug
Intervention Name(s)
nimotuzumab
Other Intervention Name(s)
Taixinsheng
Intervention Description
nimotuzumab,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo，400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.
Primary Outcome Measure Information:
Title
overall survival（OS）
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Time to Progression（TTP）
Time Frame
up to 3 years
Title
Progression Free Survival（PFS）
Time Frame
up to 3 years
Title
Objective Response Rate（ORR）
Description
Appeared efficacy from the beginning until proven disease progression
Time Frame
Once every eight weeks，up to 5.4 months
Title
Disease Control Rate（DCR）
Description
The number of cases in remission after being treated and the disease stabilized accounts the total percentage of the number of evaluable patients
Time Frame
Once every eight weeks，up to 5.4 months
Title
Clinical Benefit Response（CBR）
Description
Only evaluated the symptomatic patients in the study
Time Frame
Once a week,up to 5.4 months
Title
To determine the safety of the treatment with Nimotuzumab and Gemcitabine (NCI Common Terminology Criteria for Adverse Events v4.03)
Time Frame
Any adverse medical events occur from the beginning of receiving study drug to the end of treatment after 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:18-75 years old KPS≥60 Histological or cytological diagnosis that are unsuitable for radical radiotherapy or surgical treatment of locally advanced or metastatic pancreatic adenocarcinoma (≥6 months to the last adjuvant chemotherapy) Has at least one objective measurable lesion can be evaluated according to Response Evaluation Criteria in Solid Tumors1.1(Helical CT examination of the longest diameter of target lesions≥10mm, such as lymph node metastasis only need the shortest path ≥15mm) Life expectancy ≥12 weeks K-RAS tumor tissue detected as the wild-type Aspartate transaminase（AST）/aminotransferase（ALT）≤2.5×ULN，AST /ALT≤5×ULN（if liver metastases）；Total bilirubin≤2×ULN，Total bilirubin≤3×ULN（if liver metastases）；Absolute neutrophil count≥1.5×109/L；Blood platelet≥100×109/L；Hemoglobin≥90 g/L；Creatinine clearance≥60ml/min Volunteered to participate this study, written informed consent and has a good compliance Patients of childbearing age and their spouses are willing to take contraceptive measures Exclusion Criteria: Before this study had received the following treatments：As a means of anti-tumor palliative chemotherapy and molecular targeted therapy.Target lesion had received radiotherapy without progression.within 4 weeks or be participating in clinical trials of other therapeutic/ interventionist clinical trial. Undergone major surgery within 4 weeks. The brain metastasis or leptomeningeal metastasis. Has a history of malignancy other than the pancreatic cancer (except for the cured cervix in situ or basal cell carcinoma, and a five-year cure other cancers). The merger has symptoms of ascites and requires clinical treatment. Accompanied by other serious disease, including but not limited:Congestive heart failure which is difficult to control (NYHA III or IV), Unstable angina, Poorly controlled arrhythmia, Uncontrolled moderate to severe hypertension(systolic blood pressure（SBP）>160 mm Hg or diastolic blood pressure（DBP）>100 mm Hg).Active infection.Diabetes which is difficult to control.Has mental illness which impacts the informed consent and / or compliance program.HIV infection.There is serious illness that other researchers consider is unsuitable to participate this study. Known allergy to anti-EGFR antibody formulations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shukui qin, MD, PHD
Phone
025-80864541
Email
qinsk@csco.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shukui qin, MD, PHD
Organizational Affiliation
81th Hospital of PLA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
jin li, MD, PHD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qiong wu, PhD
First Name & Middle Initial & Last Name & Degree
qiong wu, PhD
Facility Name
Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhendong chen, PhD
First Name & Middle Initial & Last Name & Degree
zhendong chen, PhD
Facility Name
Beijing Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chunmei bai, PhD
First Name & Middle Initial & Last Name & Degree
chunmei bai, PhD
Facility Name
Chinese Academy of Medical Sciences Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lin yang, PhD
First Name & Middle Initial & Last Name & Degree
lin yang, PhD
Facility Name
PLA General Hospital (301 Hospital)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yi hu, PhD
First Name & Middle Initial & Last Name & Degree
yi hu, PhD
Facility Name
Affiliated Hospital of Military Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianming xu, PhD
First Name & Middle Initial & Last Name & Degree
jianming xu, PhD
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chunyi hao, PhD
First Name & Middle Initial & Last Name & Degree
chunyi hao, PhD
Facility Name
Fuzhou General Hospital of Nanjing Military Region
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xuenong ouyang, PhD
First Name & Middle Initial & Last Name & Degree
xuenong ouyang, PhD
Facility Name
Fujian Provincial Tumor Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianwei yang, PhD
First Name & Middle Initial & Last Name & Degree
jianwei yang, PhD
Facility Name
Cancer Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yuxian bai, PhD
First Name & Middle Initial & Last Name & Degree
yuxian bai, PhD
Facility Name
Jiangyin City People's Hospital
City
Jiangyin
State/Province
Jiangsu
ZIP/Postal Code
214400
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qiong wang, PhD
First Name & Middle Initial & Last Name & Degree
qiong wang, PhD
Facility Name
Jiangsu Province Tumor Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jia chen, PhD
First Name & Middle Initial & Last Name & Degree
jia chen, PhD
Facility Name
Second Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yang zhang, PhD
First Name & Middle Initial & Last Name & Degree
yang zhang, PhD
Facility Name
Shanghai Jiaotong University Affiliated Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jun zhang, PhD
First Name & Middle Initial & Last Name & Degree
jun zhang, PhD
Facility Name
Shanghai Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhiqiang meng, PhD
First Name & Middle Initial & Last Name & Degree
zhiqiang meng, PhD
Facility Name
Shanghai Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tianshu liu, PhD
First Name & Middle Initial & Last Name & Degree
tianshu liu, PhD
Facility Name
Shanghai Huashan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
deliang fu, PhD
First Name & Middle Initial & Last Name & Degree
deliang fu, PhD
Facility Name
First People's Hospital Cancer Center, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liwei wang, PhD
First Name & Middle Initial & Last Name & Degree
liwei wang, PhD
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhaoshen li, PhD
First Name & Middle Initial & Last Name & Degree
zhaoshen li, PhD
Facility Name
Affiliated Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wenchao liu, PhD
First Name & Middle Initial & Last Name & Degree
wenchao liu, PhD
Facility Name
General Hospital of Chengdu Military Region
City
Chendu
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tao zhang, PhD
Facility Name
First Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
nong xu, PhD
First Name & Middle Initial & Last Name & Degree
nong xu, PhD
Facility Name
Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ying yuan, PhD
First Name & Middle Initial & Last Name & Degree
ying yuan, PhD
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hongming pan, PhD
First Name & Middle Initial & Last Name & Degree
hongming pan, PhD
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
haijun zhong, PhD
First Name & Middle Initial & Last Name & Degree
haijun zhong, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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