Pancreatic Adenocarcinoma
Conditions
Interventions
Experimental Group:Sintilimab combined with paclitaxel (albumin-bound) and gemcitabine
Sponsors
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged 18 to 75 years, male or female; 3. Pancreatic cancer diagnosed by histopathological examination; 4. Unresectable initial local progress is not suitable for patients with concurrent radiotherapy and chemotherapy and who have not received anti-tumor therapy (radiotherapy, chemotherapy, targeted or immunotherapy, etc.); 5. According to the evaluation criteria for the efficacy of solid tumors (RECIST Version 1.1), there is at least one imaging measurable lesion; 6. ECOG score 0-1 points; 7. Expected survival time> 3 months; 8. Sufficient organ function, subjects need to meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) >= 1.5x10^9/L without using granulocyte colony stimulating factor in the past 14 days. (2) In the case of no blood transfusion in the past 14 days, platelets >=100x10^9/L. (3) If there is no blood transfusion or erythropoietin in the past 14 days, hemoglobin>9g/dL; (4) Total bilirubin= 60 ml/min; (7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN; (8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is out of the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; 9. For female subjects of childbearing age, they should receive a urine or serum pregnancy test and the result is negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-bearing age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases other than pancreatic cancer within 5 years before the first administration 2. Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulation or synergistic inhibition of T cell receptors 3. Received Chinese patent medicines with anti-tumor indications or immunomodulatory drugs within 2 weeks before the first administration 4. Active autoimmune diseases requiring systemic treatment occurred within 2 years before the first administration. 5. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Those who are known to be allergic to the active ingredients or excipients of Sintilimab, gemcitabine and albumin paclitaxel; 8. Known human immunodeficiency virus (HIV) infection history (ie HIV 1/2 antibody positive); 9. Uncontrolled active hepatitis B (defined as HBsAg positive and the number of copies of HBV-DNA detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center); 10. Live vaccine has been vaccinated within 30 days before the first administration (cycle 1, day 1); 11. There are any serious or uncontrollable systemic diseases and the 24-hour urine protein quantification is confirmed to be> 1.0 g; 12. Patients with mental disorders who cannot cooperate with treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical conversion rate;R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Event-free survival;Safety; | — |
Countries
China
Contacts
Public ContactSun Yongwei
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed