advanced pancreatic cancer
Conditions
Interventions
Experimental group1:gemcitabine combined with Sintilimab combined with IBI310 combined with regofinib combined with GM-CSF
Experimental group2:gemcitabine combined with Sintilimab combined with regofinib combined with GM-CSF
Sponsors
First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed pancreatic cancer; 2. Aged 18 to 75 years, gender is not limited; 3. Expected survival period >= 3 months; 4. ECOG score 0-1 points; 5. At least 1 measurable lesion according to RECIST 1.1 criteria and iRECIST criteria. 6. No previous treatment with regorafenib, gemcitabine and PD-1/PD-L1/CTLA4 monoclonal antibody. 7. The function of major organs is good, that is, the relevant inspection indicators within 14 days before enrollment meet the following requirements: (1) Hemoglobin >= 90 g/L (no blood transfusion within 14 days); (2) Neutrophil count > 1.5x10^9/L; (3) Platelet count >= 100x10^9/L; (4) Total bilirubin = 60 ml/min (Cockcroft-Gault formula); (7) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%. 8. Sign the informed consent form and the compliance is good, and the family members agree to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors in the past or at the same time, except for basal cell carcinoma of the skin and carcinoma in situ of the cervix that have been cured; the patient's combined small gastric stromal tumor and other tumors, and other early-stage tumors after radical treatment, Other tumors that the investigator judges will not affect the patient's life in the short term can be excluded. 2. Participated in clinical trials of other drugs within four weeks; 3. Patients with known CNS metastasis or a history of CNS metastasis before screening. For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; 4. Those with a history of unstable angina pectoris; those newly diagnosed with angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QTcF: male >= 450 ms, female >= 470 ms) requires Long-term use of antiarrhythmic drugs and New York Heart Association class >= II cardiac insufficiency; 5. Urine routine indicates urine protein >=++ and confirmed 24-hour urine protein quantification >1.0 g; 6. For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: should be surgically sterilized, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period; 7. Have used immune targeted therapy drugs; 8. Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients who need corticosteroids; 10. History of chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative colitis, Crohn's disease, history of chronic diarrheal diseases such as irritable bowel syndrome; history of sarcoidosis Medical history or history of tuberculosis; history of active hepatitis B, hepatitis C and HIV infection; 11. Patients with hypersensitivity to human or murine monoclonal antibodies; 12. Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; 13. Pleural effusion or ascites with clinical symptoms requiring clinical intervention; 14. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progressives free survival;Overall survival;6 months Progressives free survival rate;6 months Overall survival rate;12 months Progressives free survival rate;12 months Overall survival rate;Disease Control Rate;safety;Quality of life score; | — |
Countries
China
Contacts
Public ContactLi Wei
First Affiliated Hospital of Soochow University
Outcome results
None listed