pancreatic cancer
Conditions
Interventions
Experimental group:High-intensity focused ultrasound therapy (HIFU) combined with adalimumab and XELIRI
Sponsors
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18-75 years old, both sexes; 2. By histology or cytological diagnosis of locally advanced or metastatic pancreatic cancer subjects; 3. No prior irinotecan - and fluorouracil-based chemotherapy for locally advanced or metastatic pancreatic cancer, allowing chemotherapy as part of neoadjuvant/adjuvant therapy as long as treatment was completed at least 12 months before diagnosis of locally advanced or metastatic disease; 4. Always not received immunosuppressive therapy; 5. At least have a measurable lesions (according to the standard, RECIST1.1 tumor lesions on CT scan length to diameter 10 mm, or scanning layer thickness is not more than 5 mm); 6. ECOG PS score: 0 and 1; 7. The predicted survival time is more than 3 months; 8. Major organs function is good, namely drug related within 14 days before check index meet the following requirements: A) blood routine inspection: i. hemoglobin = 100 g/L; ii. Neutrophil count > 1.5×109/L; iii. Platelet count = 100×109/L; B) biochemical check: i. Total bilirubin = 1.5×ULN (upper limit of normal); Ii. Blood alanine aminotransferase (ALT) or blood aspertate aminotransferase (AST) 2.5 x ULN or less; If there was liver metastasis, ALT or AST = 5×ULN; Endogenous creatinine clearance = 60 ml/min (Cockcroft-Gault formula); iii. Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = 50% 9. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment. Women of childbearing age and men (and women of childbearing age sex) must agree during treatment and final treatment of contraception within six months; Subjects were willing to join in this study, and sign the informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other uncured malignant tumors at the same time; Patients with previous PD-1/PD-L1 antibody exposure; 2. 3. Can be removed surgically or radical radiotherapy subjects; 4. A history of bleeding, screening occurred within 4 weeks before any serious grading to 3 degrees or above of bleeding events in CTCAE4.0 subjects; 5. Routine urine prompt urine protein p + + and confirmed that the 24 hours urinary protein quantitative > 1.0 g; 6. Poorly controlled hypertensive subjects; 7. Use drug first occurred within 4 weeks before serious infection of the subjects, including but not limited to require hospitalization infection complications, 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. A history of chronic autoimmune disease, such as systemic lupus erythematosus (sle), ulcerative colitis, crohn's disease and other inflammatory bowel disease, etc. Only need hormone replacement therapy hypothyroidism by and don't need systemic treatment of skin disease (except such as vitiligo, psoriasis, or hair loss). 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; 18. Researchers think that should not be other information into the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS(progression free survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(Objective Response Rate);DCR(Disease control rate);OS(overall survival);Adverse Events; | — |
Countries
China
Contacts
Public ContactWei Zhu
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Outcome results
None listed