Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02395016 : A Study of Nimotuzumab Combinated With Gemcitabine in K-RAS Wild-type Locally Advanced and Metastatic Pancreatic Cancer
PhasePhase 3
AgesMin: 18 Years Max: 75 Years
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02395016      |      Link to official Clinicaltrials.gov listing
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