cancer of pancreas
Conditions
Interventions
test team:Gio combined with Apatinib mesylate
control group:APA imatinib mesylate
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent; 2. male or female aged 18-75 years; 3. Patients with advanced and / or metastatic pancreatic cancer confirmed by histology or cytology; 4. Patients who had not previously been exposed to apatinib and had received gemcitabine chemotherapy; 5. The estimated survival time is more than 3 months; 6. the score of physical state of the eastern cancer cooperation group ECOG was 0-2 points; 7. The patient may have a history of brain / meningeal metastasis, but must undergo local treatment (surgery / radiotherapy) before randomization and clinical stability for at least 2 months. (use of glucocorticoid drugs before or at the same time. But it must be non-high dose, dose stable, after random without adjustment, high dose is defined as dexamethasone 20mg, other glucocorticoid drugs corresponding conversion; According to RECIST v1.1 guidelines, at least one lesion (no previous radiotherapy). At baseline, the longest diameter = 10 mm (except lymph nodes) was accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (the preferred intravenous contrast medium); 8. The short axis of lymph node must be more than 15mm, and the lesion is suitable for repeated accurate measurement. If the lesion located in the previously irradiated area clearly proves to be progressive, the lesion can be used as a measurable lesion; 9. adequate organ and bone marrow functions are defined as follows: Hemoglobin = 9 g/dL Absolute neutrophil count = 1.0 × 10^9/L; Platelet = 75×10^9/L; Total serum bilirubin = 1.5×normal upper limit is not suitable for Gilbert syndrome (persistent or recurrent hyperbilirubinemia, mainly unconjugated bilirubin). Patients with no evidence of hemolysis or abnormal liver pathology) may consult a doctor. ALT and AST = 2.5×ULN; for patients with liver metastasis, ALT and AST = 5×ULN Creatinine clearance calculated using Cockcroft-Gault formula (using actual body weight). Or the creatinine clearance calculated by measuring 24 hours urine samples was more than 40 mL/min. (if both methods were used. The values measured using 24-hour urine collection will be used to determine eligibility); 10. Women of childbearing age must undergo pregnancy tests (serum or urine) within 7 days of admission. The results were negative and willing to use appropriate methods of contraception during the trial and within 6 months after the last administration of the experimental drug. For men who agreed to take the appropriate prescription during the trial and 6 months after the last administration of the experimental drug. Legal contraception; 11. Patients voluntarily participate in the trial and sign informed consent, good compliance.
Exclusion criteria
Exclusion criteria: 1. Patients with hypertension who could not be reduced to normal range by antihypertensive drugs (systolic blood pressure > 140 mmHg / diastolic blood pressure > 90 mm Hg), patients with coronary heart disease =II, arrhythmia (including prolonged QTc interval > 450msin males, females > 470ms) and patients with cardiac insufficiency; 2. have a variety of factors affecting oral medication (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); Special attention: patients at risk of gastrointestinal bleeding may not be included in the group, including those with active peptic ulcer lesions and stool occult blood + +; those with a history of black stool and hematemesis within 3 months; For stool occult blood + +) and primary gastric neoplasms have not been surgically resected, gastroscopy must be performed, such as ulcerative gastric cancer, which is considered by the doctor to be likely to cause bleeding; 3. the patients with abnormal coagulation function (INR >1.5×ULNN APTT >1.5×ULNN) had a tendency to bleed. Patients with symptomatic central nervous system metastasis; Pregnant or lactating women; anyone to be identified do not appropriate to be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| size of the lesions; | — |
Countries
China
Contacts
Public ContactYanqiao Zhang
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed