Advanced pancreatic cancer
Conditions
Interventions
Group 1:Recombinant Human Endostatin Injection
Group 2:Capecitabine Tablet
Sponsors
Daping Hospital, Third Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must satisfy all of the following criteria can be enrolled into this trial: 1. pathologically confirmed advanced pancreatic cancer (all other tissue types are excluded) in patients with unresectable operation or operation isnt available; 2. according to the RECIST 1.1 standard, patients with at least one can measure the diameter of target lesions (tumors CT scan length diameter >=10 mm, lymph node lesions by CT scanning short diameter >=15 mm, slice thickness less than 5 mm; and has not received local treatment); 3. aged 18~75 years old; 4. ECOG PS score: 0~1; 5. the expected survival >=3 months; 6. subjects received other treatment caused damage has been restored, the interval >=6 weeks accept nitroso or mitomycins; accept other cytotoxic drugs, radiotherapy or operation of over 4 weeks, and the wound has healed completely; 7. signed the informed consent; 8. good compliance, can follow up.
Exclusion criteria
Exclusion criteria: Exclusion criteriaComply with any one of the following criteria should not be enrolled into this study: 1. before or simultaneously with other malignant tumors, but healed skin basal cell carcinoma and cervical carcinoma in situ except; 2. Patient had received previous vascular endothelial growth inhibition(such as bevacizumab treated patients, Regorafenib etc.); 3. Patienthas a clear tendency in patients with gastrointestinal bleeding. Include the following: the local active ulcerative lesions, and fecal occult blood (+ +); 2 months have melena, hematemesis history; researchers think that possibly has the massive hemorrhage of digestive tract; 4. people who are allergic or on protein biological products have a history of allergy; 5. baseline is the transfer of the central nervous system of evidence or previous history of central nervous system metastasis patients. For clinical patients with suspected metastasis of the central nervous system, randomized within 14 days must be CT or MRI scan, to exclude the transfer of the central nervous system; 6. imaging revealed a main organ tumor load is too high (such as: liver tumor load >50%); 7. The main organs function abnormal, namely the relevant indexes to the extent: (1) blood routine examination: A. Hb=1.25×ULN (the upper limit of normal value); B. ALT or AST >=1.5×ULN; such as liver metastasis, ALT or AST >=2.5×ULN; C. Creatinine clearance rate = 60 ml/min (Cockcroft-Gault formula); cholesterol>1.5 * ULN D. triglyceride > 2.5×ULN; (3) by Doppler echocardiography: left ventricular ejection fraction (LVEF 140mmHg, diastolic pressure > 90 mmHg), with I above the level of myocardial ischemia or myocardial infarction, arrhythmia (including male QTcF: male>=450 ms, female >=470 ms) and cardiac dysfunction; 9. urine routine urinary protein >= ++ and confirmed that 24 hour urinary protein quantitative >1.0 g; 10. long term wound healing of long or incomplete fracture; 11. blood coagulation dysfunction, with bleeding tendency (14 days before randomization must meet: without the use of anticoagulants in case of INR in the normal range); 12. Screening hyperactivity / venous thrombosis occurred within one year before, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 13. use of anticoagulants or vitamin K antagonists such as Hua Falin, heparin or its analogues in the treatment of the patients; in the prothrombin time international normalized ratio (INR) <=1.5, allows to prevent using small doses of Hua Falin (1 mg orally, once daily) or small dose aspirin (daily amount of not more than 100 mg); 14. pregnant patient or lactating women or the preparation of fertility of female / male. For female subjects: should be operation sterilization, postmenopausal patients, or agreed to in the study of treatment within 6 months after the end of treatment period, use a medically acceptable contraceptive measures (such as intrauterine device [IUD], the pill or condoms); in the study before entering the group within 7 days of serum or urine pregnancy test must be negative, and must not be breast-feeding. Male subjects: should be operation sterilization, or agree to us
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;QoL; | — |
Contacts
Public ContactDong Wang
Cancer Center, Daping Hospital, Third Military Medical University
Outcome results
None listed