pancreatic cancer
Conditions
Interventions
Three groups:PD-1 monoclonal antibody combined with Apatinib versus PD-1 monoclonal antibody combined with capecitabine versus capecitabine alone
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Capecitabine has not been used in patients with locally advanced and metastatic pancreatic ductal adenocarcinoma confirmed by imaging, histological and/or cytological examinations after first-line gemcitabine therapy failed; 2. Imaging diagnosis has at least one measurable lesion, such as: CT, MRI can measure the maximum diameter of the lesion (> 1 cm); 3. male or female, aged 20 to 80 years; 4. physical condition: ECOG score is less than or equal to 2 points; 5. the expected survival time is longer than 3 months, and can be followed up; 6. Within 7 days before treatment, the results of blood routine, liver, kidney function and hemagglutination tests met the following criteria: WBC (> 3.5 *109/L), platelet (> 80 *10^9/L), neutrophil (> 1.5 *10^9/L), hemoglobin (> 90g/L), aspartate aminotransferase (AST) normal upper limit). ULN (liver metastasis < 5 *ULN), alanine aminotransferase (ALT) < 2.5 *ULN (liver metastasis < 5 *ULN), total bilirubin (TIBC) < 1.5 *ULN, serum creatinine (CR) < 1.0 *ULN, prothrombin time, partial thromboplastin time, plasma fibrinogen, thrombin time in the normal range; 7. Female subjects must take effective contraceptive measures (e.g. oral contraceptive, contraceptive injection, intrauterine device, double block method, contraceptive patch, male partner sterilization) throughout the study period; serum or urine pregnancy test results must be negative during the screening and throughout the study period; 8. male patients should take effective contraception measures within 1 months after receiving chemotherapy and completion of chemotherapy; 9. willing to comply with the prohibitions and restrictions specified in the research plan; 10. patients voluntarily signed informed consent and had good compliance.
Exclusion criteria
Exclusion criteria: 1. 30 days before the first drug administration, other research drugs have been received; 2. patients with clinical symptoms of brain metastases (except radiotherapy); 3. a history of other malignancies; 4. active virus or bacterial infection, which can not be controlled; 5. People who are known to have positive serological reactions to HIV and syphilis, active hepatitis B virus or hepatitis C virus infection; 6. suffering from mental illness or uncontrollable systemic disease or any concomitant disease, such as uncontrollable heart disease or lung disease, diabetes, etc., can not meet the research treatment and monitoring requirements; 7. known to be allergic to any component of the drug; 8. active rheumatic diseases; 9. stroke events and / or cerebral ischemia occurred before December; 10. severe hepatorenal insufficiency (grade 4); 11. skin wound, wound site, severe ulcer or fracture of mucosa were not completely healed; 12. Significant cardiovascular abnormalities (e.g. myocardial infarction, superior vena cava (SCV) syndrome, heart disease above grade 2 diagnosed by the New York Heart Association (NYHA) classification criteria within the first three months of enrollment (see Appendix 3), active severe clinical infections (> NCI-CTCAE Version 4.0 Level 2 infection criteria); 13. patients with bleeding tendency or coagulation disorders; 14. patients with drug control hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg); 15. participating in other clinical trials; 16. patients who had undergone organ transplantation before; 17. patients with random urine protein were more than 3+ or 24 hours urinary protein quantitation over 500mg; 18. poor compliance; 19. pregnant or lactating women; 20. those who are receiving Immunoenhancers or immunosuppressive drugs; 21. patients with immune deficiency or autoimmune diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR;DCR;QoL;Safety; | — |
Countries
China
Contacts
Public ContactWang Hongxia
Shanghai General Hospital
Outcome results
None listed