Liver metastasis of pancreatic cancer
Conditions
Interventions
experimental group:PD-1+AG
Sponsors
RuiJin Hospital Ethics Committee Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, male or female; 2. Histologically or Cytologically confirmed pancreatic adenocarcinoma with synchronous liver metastases; 3. There should be at least one measurable metastatic liver disease; 4. If cirrhosis is present, the child-pugh score should be less than or equal to 7; 5. Patients have never received systematical anti-cancer therapy; For patients received neoadjuvant/adjuvant and radical concurrent chemoradiotherapy, the time from the last chemotherapy to recurrence or progression was more than 6 months. 6. Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion which has never received local treatment like radiotherapy(The lesion located in previous radiotherapy areas can also be selected as target lesions if the progress confirmed.) 7. ECOG 0-1; 8. Expected survival >=12 weeks; 9. Essential organs function must meet the following criteria (Any blood products, growth factor, leucocyte promoting drugs, platelet promoting drugs, drugs for anemia are not allowed in 14 days before the first use of the experimental medication): 1) Absolute neutrophil count (ANC) >= 1.5x10^9/L; 2) Platelet >= 85 * 10^9/L; 3) Hemoglobin >= 90g/L; 4) Serum Albumin >= 30g/L; 5) Total bilirubin 60 mL/min; 7) Activated Partial Thromboplastin Time and International Standardized Ratio <= 1.5 ULN (Patients using stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin and INR is within the expected range of anticoagulants can be selected.) 10. Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. 11. Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with central nervous system metastasis. 2. Patients only have local advanced diseases. 3. The liver was treated with radiation; 4. Patients have uncontrolled pleural, pericardial or abdominal effusion requiring drainage; 5. Patients with history of allergy to monoclonal antibodies, any component of SHR-1210, paclitaxel(Albumin Bound) and Gemcitabine. 6. Patients have ever received anti PD-1 or anti PD-L1 therapy in the past. 7. Patients have accepted any experimental medication.within 4 weeks before the first dose of our experimental medication administration. 8. Patients are enrolled in another clinical trial except for observational clinical trial (Non-interventional) or the follow-up of the interventional clinical trial. 9. Patients accepted the last dose of anti-cancer therapy (including radiotherapy) within 4 weeks before the first dose of experimental medication administration. 10. Subjects required systemic treatment with corticosteroids (> 10 mg/day equivalent of prednisone) or other immunosuppressive agents within 2 weeks prior to first use of the study drug. 11. Patients who ever received anti-cancer vaccine or have received live vaccine within 4 weeks before the first dose of administration. 12. Patients who have received major surgery within 4 weeks before the first dose of administration. 13. Patients with active autoimmune diseases, history of autoimmune diseases. 14. History of immunodeficiency, including HIV positive test, or other acquired, congenital immunodeficiency disorders, or history of organ transplantation and allogeneic bone marrow transplantation. 15. Patients with uncontrolled cardiovascular clinical symptoms or diseases. 16. Severe infections occurred within 4 weeks before the first administration. 17. History of interstitial lung disease and non- infectious pneumonia. 18. Patients with active pulmonary tuberculosis (APTB) infection confirmed by medical history or CT examination. 19. Patients with active hepatitis B or hepatitis C. 20. Pregnant or lactating women. 21. According to the researchers, participants have other factors that may force them to end up the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;DoR;OS; | — |
Countries
China
Contacts
Public ContactQian Zhan
Outcome results
None listed