pancreatic cancer
Conditions
Interventions
experimental group:Adbelimumab plus Chemotherapy (AG)
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18-80 years old, both sexes; 2. Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma with stage IIIb /IV disease (according to the UICC/AJCC staging system, 8th edition 2017); 3. No previous systemic therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma was allowed to use chemotherapy and/or radiotherapy as part of neoadjuvant/adjuvant therapy, as long as treatment was completed at least 12 months before the diagnosis of advanced or metastatic disease; 4. No prior radiotherapy (unless there is at least one measurable lesion in the nonirradiated area); 5. At least one measurable lesion (tumor lesion with CT scan length =10 mm and slice thickness = 5 mm according to RECIST1.1 standard); 6.ECOG PS score: 0-2; 7. The main organ function was good, that is, the relevant examination indicators met the following requirements within 14 days before randomization: a) Routine blood test: i. hemoglobin = 100 g/L (no blood transfusion within 14 days); ii. Neutrophil count > 1.5×109/L; iii. Platelet count = 100×109/L; b) Biochemical tests: i. Total bilirubin = 1.5×ULN (upper limit of normal); ii. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5×ULN; If there was liver metastasis, ALT or AST = 5×ULN; Endogenous creatinine clearance = 60 ml/min (Cockcroft-Gault formula); iii. 8. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment. Women of reproductive age and men (who have sex with a woman of reproductive age) must agree to contraception during treatment and within 6 months of the last treatment; The subjects voluntarily joined this study and signed the informed consent form, with good compliance and cooperation in follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other uncured malignant tumors at the same time; 2.Patients with previous PD-1/PD-L1 antibody exposure; 3. Subjects amenable to surgical resection or radical radiotherapy; 4.Patients with a history of bleeding and any bleeding event of CTCAE4.0 grade 3 or above within 4 weeks before screening; 5. Urine routine test showed urinary protein =++ and confirmed 24-hour urinary protein quantitation >1.0 g; 6. Poorly controlled hypertensive subjects; 7. Subjects who experienced a serious infection within 4 weeks prior to the first dose of medication, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc. During screening, a subject with a serious active infection requiring intravenous antibiotic treatment developed; 8. Subjects requiring systemic therapy with corticosteroids (>10 mg/ day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose. Inhaled or topical corticosteroids and adrenal-hormone-replacement therapy at a efficacy dose of prednisone of more than 10 mg per day were allowed in the absence of active autoimmune disease. 9. History of chronic autoimmune diseases, such as systemic lupus erythematosus, ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases; Exceptions are hypothyroidism requiring only hormone replacement therapy and skin conditions (such as vitiligo, psoriasis, or alopecia) that do not require systemic treatment. 10. Uncontrolled arrhythmias (including QTc interval =450 ms in men and =470 ms in women) with grade II or higher myocardial ischemia or infarction. Subjects with NYHA class ?-? cardiac dysfunction or left ventricular ejection fraction (LVEF) < 50% by echocardiography were excluded. 11. Prospective or previous recipients of tissue/organ transplantation; 12. Subjects who have received or will receive live vaccine within 30 days before the first dose; 13. Subjects with a history of difficult to control mental illness or severe intellectual or cognitive impairment; 14. Active hepatitis subjects: hepatitis B virus surface antigen (HBV sAg) positive and HBV DNA= 2000 IU/mL, hepatitis C virus antibody (HCV Ab) positive, HCV RNA positive, and abnormal liver function, combined with hepatitis B and hepatitis C co-infection; 15. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 16. Allergic to test drugs; 17. Women who are pregnant, lactating or have given birth but refuse to use contraception; Other conditions considered by the investigator to be ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;overall survival;Disease control rate;safety; | — |
Countries
China
Contacts
Public ContactXiaofeng SUN
Jiangsu Cancer Hospital
Outcome results
None listed