Pancreatic cancer
Conditions
Interventions
Experimental group:Adebrelimab combined with AG
Sponsors
Fudan University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must meet all of the following criteria to be enrolled in this study: 2. Signed informed consent; 3. Age 18-75 years old; 4. Histologically or cytologically confirmed pancreatic gland; 5. Unresectable locally advanced or metastatic pancreatic cancer judged by the investigator; 6. Disease progression after receiving at least one prior systemic therapy; 7. No prior immunotherapy; 8. No prior gemcitabine-based chemotherapy; 9. Have at least one measurable lesion (according to RECIST1.1 criteria); 10. ECOG score is 0~1 point; 11. Estimated survival time greater than 3 months; 12. Within 28 days before the first dose, laboratory examination with adequate organ function; (1) Blood routine: WBC >=3.0×10^9/L; ANC>=1.5×10^9/L; PLT>=100×10^9/L; HGB>=90g/L; (2) Liver function: AST=60mL/min; (4) Coagulation function: INR<=1.5, APTT<=1.5×ULN; (5) There was no obvious abnormality in the electrocardiogram; 13. Male subjects, as well as females of childbearing age, must use contraception for 3 months from the start of the first dose to the last use of study drug.
Exclusion criteria
Exclusion criteria: 1. Subject has any known active autoimmune disease; 2. Subject has any complications requiring systemic treatment with glucocorticoids such as prednisone (>10mg/day) or has used immunosuppressive drugs within 14 days prior to the first dose; 3. Subjects have received tumor vaccines or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin or immune cell therapy) within 1 month before the first dose; 4. Subjects are participating in other clinical trials or have received drug intervention from other clinical trials within 4 weeks before the first dose; 5. Subject has other malignant tumors that require treatment; 6. Subject has had a significant cardiovascular disease in the past; 7. Subject has a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 8. Subject has a positive serum test for HIV; 9. Active hepatitis B (HbsAg positive and HBV-DNA >=103copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive, and requiring antiviral therapy); 10. Presence of allergy or hypersensitivity reaction to monoclonal antibodies; 11. Presence of allergic reactions to gemcitabine and nab-paclitaxel; 12. Diseases or abnormal laboratory indicators that in the opinion of the investigator will affect the results of the study, or are not in line with the interests of the subjects, should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Security; | — |
Countries
China
Contacts
Public ContactJin Xu
Fudan University Affiliated Cancer Hospital
Outcome results
None listed