pancreatic cancer
Conditions
Interventions
experimental group:carrelizumab combined with S-1
Sponsors
SIR Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Aged between 18 and 75 years; 3. Pathologically diagnosed as adenocarcinoma; 4. Macroscopic resection; 5. no history of any systemic treatment or radiotherapy; 6. resection within 12 weeks; 7. no evidence of metastatic disease,malignant ascites,or pleural effusion; 8. Adequent organ function; 9. Life expectancy >= 3 months; 10. Women of childbearing age must take a pregnancy test (serum or urine) within 7 days before joining the group, and the result is negative, and are willing to take effective contraceptive measures during the entire study period.
Exclusion criteria
Exclusion criteria: 1. Suffer from other active malignant tumors within 5 years or at the same time; 2. Known to be allergic to the study drug or any of its excipients or have a severe allergic reaction to other monoclonal antibodies; 3. Patients with residual lesions, recurrence and metastasis during the screening period; 4. Patients with moderate or severe ascites with clinical symptoms that require therapeutic puncture, drainage, or Child-Pugh score > 2; uncontrolled or moderate or above pleural effusion and pericardial effusion; 5. Inability to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption; 6. Suffer from congenital or acquired immune deficiencies (such as HIV-infected persons); 7. Suffer from active, known or suspected autoimmune diseases. Subjects with hypothyroidism who only need hormone replacement therapy and skin diseases without systemic therapy can be selected. 8. Past interstitial lung disease, or (non-infectious) pneumonia and need oral or intravenous steroid therapy. 9. Long-term use of systemic hormones (dose equivalent to > 10 mg prednisone/day) or any other form of immunosuppressive therapy is required. 10. Use immunosuppressive agents or systemic hormone therapy within 14 days before starting the study treatment to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other curative hormones); 11. Active infections requiring systemic treatment (except viral hepatitis); 12. Untreated active hepatitis; combined hepatitis B and hepatitis C co-infection; 13. Patients who are planning to undergo or have previously received organ or allogeneic bone marrow transplantation; 14. Heart disease that is not well controlled; 15. A history of gastrointestinal bleeding or a clear gastrointestinal bleeding tendency within 3 months before signing the informed consent, such as: esophageal varices with bleeding risk, local active ulcer lesions, persistent stool occult blood positive can not be included in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;AEs; | — |
Countries
China
Contacts
Public ContactHong Yu
SIR Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed