pancreatic cancer
Conditions
Interventions
Test group:nimotuzumab+Gemcitabine
control group:Placebo+Gemcitabine
Sponsors
81th Hospital of PLA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. KPS >=60; 3. Histological or cytological diagnosis that are unsuitable for radical radiotherapy or surgical treatment of locally advanced or metastatic pancreatic adenocarcinoma (longer than 6 months to the last adjuvant chemotherapy); 4. Has at least one objective measurable lesion can be evaluated according to RECIST1.1(Helical CT examination of the longest diameter of target lesions >=10mm, such as lymph node metastasis only need the shortest path >=15mm) 5. Life expectancy >=12 weeks; 6. K-RAS tumor tissue detected as the wild-type; 7. AST/ALT =1.5*10^9/L; Blood platelet >=100*10^9/L; Hemoglobin >=90g/L; Creatinine clearance >=60ml/min; 8. Volunteered to participate this study, written informed consent and has a good compliance; 9. Patients of childbearing age and their spouses are willing to take contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Before this study had received the following treatments: a. As a means of anti-tumor palliative chemotherapy and molecular targeted therapy; b. Target lesion had received radiotherapy without progression; c. within 4 weeks or be participating in clinical trials of other therapeutic/ interventionist clinical trial. 2. Undergone major surgery within 4 weeks; 3. The brain metastasis or leptomeningeal metastasis; 4. 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); 5. The merger has symptoms of ascites and requires clinical treatment; 6. Accompanied by other serious disease, including but not limited: a. Congestive heart failure which is difficult to control (NYHA III or IV), Unstable angina, Poorly controlled arrhythmia, Uncontrolled moderate to severe hypertension(SBP>160mmHg or DBP>100mmHg); b. Active infection; c. Diabetes which is difficult to control; d. Has mental illness which impacts the informed consent and / or compliance program; e. HIV infection; f. There is serious illness that other researchers consider is unsuitable to participat this study. 7. Known allergy to anti-EGFR antibody formulations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| over survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP;PFS;ORR;DCR;CBR;Safety; | — |
Countries
China
Contacts
Public ContactQin Shukui
Outcome results
None listed