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Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Patients with advanced pancreatic adenocarcinoma and locally advanced pancreatic adenocarcinoma diagnosed by histology or cytology; 3. Patients who have not received systemic chemotherapy in the past, or who have progressed to first-line treatment; 4. There is at least one measurable lesion (according to the RECIST 1.1 standard, the long diameter of the CT scan of tumor 1. Age: 18-70 years old; 2. Patients with advanced pancreatic cancer and locally advanced pancreatic cancer diagnosed by histology or cytology; 3. Patients who have not received systemic chemotherapy in the past, or who have progressed to first-line treatment; 4. There is at least one measurable lesion (according to the RECIST 1.1 standard, the long diameter of the CT scan of tumor lesions is >= 10mm, and the short diameter of CT scan of lymph node lesions is >= 15mm); 5. ECOG score: 0-1 points; 6. Estimated survival period >= 3 months; 7. The main organs are functioning normally, that is, they meet the following standards: (1) Routine blood examination standards must meet (no blood transfusion and blood products within 14 days): 1) ANC>=1.5x10^9/L; 2) PLT>=80x10^9/L; (2) The biochemical inspection shall meet the following standards: 1) TBIL 45 ml/min (Cockcroft-Gault formula); 8. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or a history of autoimmune disease; 2. According to NYHA standards, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%; 3. Abnormal blood coagulation function (INR>1.5 APTT>1.5 ULN), with bleeding tendency; 4. Long-term unhealed wounds or fractures; major surgical operations or severe traumatic injuries, fractures or ulcers occurred within 4 weeks; 5. Subjects with congenital or acquired immune function defects (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA test value exceeds the upper limit of normal value; hepatitis C reference: HCV virus titer or RNA test value exceeds the upper limit of normal value ); 6. Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or hyperactivity in the past 6 months (to the first SHR-1210 medication), Venous thrombosis events; 7. Subjects have active infections or have unexplained fever> 38.5 degrees during the screening period and before the first administration; 8. Patients with central nervous system metastasis; 9. Those who have received live vaccine or live attenuated vaccine within 30 days before receiving research treatment for the first time; 10. The subject has suffered from other malignant tumors in the past or at the same time; 11. Pregnant or lactating women; 12. Those who have a history of psychotropic drug abuse and cannot be quit or those who have mental disorders; 13. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 14. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Remission maintenance time;Disease control rate; | — |
Countries
China
Contacts
Shandong Provincial Hospital