Pancreatic cancer
Conditions
Interventions
Case series:Neoadjuvant therapy with PD-1 Antibody(SHR-1210) and albumin-bound paclitaxel plus Gemcitabine
Sponsors
Chinese PLA General Hospital (301 hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, male or female; 2. A confirmed diagnosis of resectable pancreatic ductal adenocarcinoma according to clinical symptoms, imaging examination, tumor markers and other auxiliary examinations or puncture pathological biopsy results; 3. According to the NCCN Guidelines 2018 V2, (1)the definition of resectable pancreatic cancer: artery: tumor does not extend to the artery (the celiac axis, superior mesenteric artery, or common hepatic artery); vein: tumor does not extend to the superior mesenteric vein or portal vein or violates 180° without involvement of the aorta and with intact and uninvolved gastroduodenal artery thereby permitting a modifed Appleby procedure; Venous: Solid tumor contact with the SMV or PV of >180°, contact of =180° with contour irregularity of the vein or thrombosis of the vein but with suitable vessel proximal and distal to the site of involvement allowing for safe and complete resection and vein reconstruction; Solid tumor contact with the inferior vena cava (IVC); 4. At least one measurable lesion by RECIST 1.1 for imaging diagnosis; 5. Previously untreated, including surgery, chemotherapy, radiation, and targeted therapy; 6. ECOG performance status 0-1; 7. Normal main organs function: (1) Hemoglobin (Hgb) >=90 g/L (no blood transfusion within 14 days); (2) Absolute neutrophil count (ANC) >=1.5 x 10^9/L; (3) Platelets (plt) >=90 x 10^9/L; (4) Total bilirubin <=2.5 ULN; (5) ALT <=2.5 ULN; AsT <=2.5 ULN; (6) Creatinine <=1.25 ULN; (7) Thyroid stimulating hormone (TSH) <= ULN (if TSH level is abnormal, T3 and T4 levels should be investigated, and then if T3 and T4 levels are normal, patients can be enrolled); (8) For patients who have not received anticoagulant therapy, international normalized ratio of prothrombin time (INR) <=1.5 and partial thromboplastin time (APTT) <=2.5 x ULN. Patients receiving total or parenteral anticoagulant therapy have a stable dose of anticoagulant for at least 2 weeks before entering the clinical study, and the results of the coagulation test within the limits of local treatment; 8. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment, and volunteer to use appropriate methods during the observation period and within 8 weeks after the last dose of study drug. For men, surgical sterilization or agree to use effective methods of birth control during the observation period and for up to 8 weeks after the last dose of study; 9. Patients volunteered to participate and signed informed consent; 10. Good compliance, and the effect and adverse reactions can be followed according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Previous anti-tumor therapy within 4 weeks before enrollment, including radiation, chemotherapy, targeted therapy, and immunotherapy; 2. Participated in clinical trials of other drugs and took other drugs within 4 weeks prior to enrollment; 3. History of any active autoimmune diseases or autoimmune diseases (eg. interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, decreased thyroid function (except patients after hormone replacement therapy)). Childhood asthma has been completely relieved and no intervention are needed as an adult can be allowed. Patients who require bronchodilators for medical intervention cant be allowed; 4. Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >=500 IU / ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of detection of analytical method), or combined hepatitis B and hepatitis C infection; 5. Uncontrolled clinical symptoms or diseases of the heart, such as (1) heart failure (NYHA II - IV); (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 6. Severe infections within 4 weeks prior to first dose (eg. intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever (>38.5k degree C) during screening/first dose; 7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 8. Vaccination of live attenuated vaccine within 4 weeks prior to the first dose or planned during the study period; 9. Have been diagnosed with another cancer within the last 5 years (except for cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer); 10. Known hypersensitivity to drugs in the study; 11. Pregnancy, breast feeding, or patients with fertility refuse to use effective methods of birth control; 12. Uncontrolled mental disease; 13. Other circumstances judged by investigator may affect the safety of patients, or collection of data and sample, such as central nervous system metastasis, severe laboratory abnormalities, and family or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathologic response, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;objective response rate, ORR;Surgical complications;safety of the neoadjuvant therapy;No delay operation rate; | — |
Countries
China
Contacts
Public ContactRong Liu
Chinese PLA General Hospital (301 hospital)
Outcome results
None listed