Pancreatic Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old, ECOG score = 3 months; 2. Patients with advanced pancreatic cancer confirmed by histopathology or cytology; 3. Imaging indicates that there are distant measurable lesions; 4. After the first-line chemotherapy fails and progresses, and the first-line chemotherapy does not use fluorouracil, platinum drugs and anti-PD-1 monoclonal antibody; 5. Patients should meet the following hematological indicators: neutrophil count >=1.5x10^9/L; hemoglobin >=10g/dL; platelet count >=100x10^9/L; 6. Patients should meet the following biochemical indicators: total bilirubin = 60ml/min; 7. Patients of childbearing age need to take appropriate protective measures (contraceptive measures or other birth control methods) before enrollment and during the trial; 8. Has signed the informed consent; 9. Able to follow the study protocol and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Have received more than second-line anti-tumor therapy; 2. The patient has a history of other tumors, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (Ta and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment) ; 3. The patient has an active bacterial or fungal infection (>= Grade 2 of NCI-CTC, 3rd edition); 4. The patient has HIV, HCV, HBV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases deemed unenrollable by the investigator; 5. Patients with autoimmune diseases or immunodeficiencies who are treated with immunosuppressive drugs; 6. Pregnant and lactating women. Women of childbearing age must have a negative pregnancy test within 7 days of enrollment; 7. Substance abuse, clinical or psychological or social factors that compromise informed consent or study conduct. May be allergic to PD-1 monoclonal antibody immunotherapy drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medium Progress-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Medium Overall survival;Objective reponse rate;Diseas control rate;Changes in serum CEA/CA199/CA125;Safety; | — |
Countries
China
Contacts
The Affiliated Drum Tower Hospital to Medical School of Nanjing University