Clinical trial NCT02395016: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Biotech Pharmaceutical Co., Ltd.
Sponsor class: OTHER
Collaborators: name: NanJing PLA 81 Hospital
name: Fudan University
First posted: 2015-03-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Survival（OS）
timeFrame: up to 3 years
Secondary outcomes:
measure: Time to Progression（TTP）
timeFrame: up to 3 years
measure: Progression Free Survival（PFS）
timeFrame: up to 3 years
measure: Objective Response Rate（ORR）
timeFrame: Once every eight weeks，up to 5.4 months
measure: Disease Control Rate（DCR）
timeFrame: Once every eight weeks，up to 5.4 months
measure: Clinical Benefit Response（CBR）
timeFrame: every 8 weeks, up to 5.4 months
measure: Number of Participants With Adverse Events
timeFrame: up to 75.2 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: PLA General Hospital (301 Hospital)
state: Beijing
city: Beijing
country: China
facility: Affiliated Hospital of Military Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fuzhou General Hospital of Nanjing Military Region
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Tumor Hospital
state: Fujian
city: Harbin
country: China
facility: Cancer Hospital of Harbin Medical University
state: Heilongjiang
city: Jiangyin
country: China
facility: Jiangyin City People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Tumor Hospital
state: Jiangsu
city: Dalian
country: China
facility: Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Jiaotong University Affiliated Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Fudan University Cancer Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Huashan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: First People's Hospital Cancer Center, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Xi'an
country: China
facility: Affiliated Xijing Hospital, Fourth Military Medical University
state: Shanxi
city: Chendu
country: China
facility: General Hospital of Chengdu Military Region
state: Sichuan
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: 81th Hospital of PLA
name: shukui qin, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: jin li, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: