pancreatic cancer
Conditions
Interventions
Single arm: experimental group:Subjects were treated with AG on days 1 and 8 of each cycle with albumin-bound paclitaxel 125mg/m2 intravenous infusion. Gemcitabine 1000mg/m2 intravenously (greater tha
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Can understand and voluntarily sign written informed consent. 2. Men or women aged 18-75 years (including the threshold). 3. Locally advanced or metastatic pancreatic ductal adenocarcinoma that is not suitable for surgical resection, confirmed by histopathological/cytological examination of the primary and/or metastatic sites. 4. The pathological biopsy of the primary site indicated at least one specific antigen; Blood target detection indicates the presence of at least one target. 5. No previous systematic treatment for unresectable metastatic pancreatic cancer. The use of fluorouracil or gemcitabine as radiotherapy sensitizers in adjuvant therapy is permitted, provided that the time from last administration to admission is greater than 6 months and that the toxic effects of prior treatment have returned to baseline or = grade 1 (except for alopecia and vitiligo; Stable or = grade 2 neuropathy induced by previous antitumor therapy). 6. Have at least one measurable lesion (non-nodular lesion with maximum diameter =10mm, or nodular lesion with short diameter =15mm) according to the solid tumor response evaluation criteria (RECIST 1.1). 7. Expected survival =6 months. 8. ECOG Fitness score 0-1. 9. No serious hematology, liver and kidney function abnormalities, consistent with the following laboratory test results: 1) Hematology: neutrophils =1.5×l09/L, platelets =75×109/L, hemoglobin =90g/L. 2) Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), without liver metastasis ALT and AST= the upper limit of normal ×3, with liver tumor or liver metastasis ALT and AST= the upper limit of normal ×5; Alkaline phosphatase (ALP) patients with no liver metastasis = the upper limit of normal ×2.5, those with liver metastasis = the upper limit of normal ×5; Total bilirubin (TBIL) = upper limit of normal ×1.5. 3) Renal function: creatinine (Cr)< 1.5 × upper limit of normal value; Creatinine clearance = 60mL/min as calculated by Cockcroft-Gault formula. 4) Coagulation function: International standardized ratio (INR) =1.5 or prothrombin time (PT) =1.5 × ULN or activated partial prothrombin time (APTT) =1.5 × ULN. 5) Urine routine detection of urinary protein concentration =1+, no edema or serum albumin level below the lower limit of normal (LLN). 10. Female subjects must meet the following criteria: 1) Surgical sterilization or postmenopausal =2 years, or women of reproductive age (including postmenopausal < 2 years) a negative pregnancy test and a willingness to use effective birth control (such as condoms or Iuds) during the study period. Contraceptives containing progesterone are not allowed. 2) Agree not to breastfeed during the study period and for at least 28 days after the last study dosing. 11. Male subjects must meet the following criteria: If sterilization is not performed and sexual activity is likely to result in pregnancy, consent to use effective contraception (such as condoms) during the study period and for at least 28 days after the last study dosing. 12. The investigator determines that the subjects are willing and able to follow the protocol requirements for the study.
Exclusion criteria
Exclusion criteria: 1. Central nervous system metastasis or meningeal metastasis that researchers believe to be uncontrolled or with clinical symptoms should be ruled out by CT/MRI if clinical symptoms suspect central nervous system or meningeal metastasis 2. Had surgery within 4 weeks prior to enrollment (except diagnostic biopsy, laparoscopic exploratory surgery, or tooth extraction). 3. Receiving or being treated with other investigational drugs within 4 weeks prior to the first study treatment. 4. Patients with malignant tumor diseases other than the tumors treated in this study (excluding malignant tumors that have been cured and have not recurred in the 3 years prior to enrollment; Completely resected basal cell and squamous cell skin cancers; Complete resection of any type of carcinoma in situ). 5. Suffering from any unstable systemic disease: including but not limited to: Active infection requiring systemic antibiotic treatment, congestive heart failure (NYHA =II), angina pectoris, myocardial infarction, angioplasty, stent implantation, or myocardial infarction within 6 months prior to study use, Stroke, transient ischemic attack (TIA), or other grade 3 or greater arterial thromboembolism events occurred in the 6 months prior to study administration; Uncontrolled hypertension (blood pressure =150/90 mmHg after standard treatment); Clinically significant QT interval prolongation (QTc male > 450 ms, female > 480 ms); Severe arrhythmias (CTCAE 5.0, grade 3 or higher) or persistent ventricular tachycardia; An ultrasound ECG scan indicated that the left ventricular ejection fraction (LVEF) was less than 50%. 6. Chronic systemic disease or history, including but not limited to: 1) Suffering from chronic digestive diseases, such as viral hepatitis, liver fibrosis and other liver diseases, recurrent indigestion or diarrhea, digestive ulcer 2) Neuropsychiatric diseases or medical history, including epilepsy, psychiatric diseases and medical history, recurrent dizziness and headache, anxiety, depression, memory and cognitive impairment, cerebrovascular accident (such as cerebral infarction) or transient ischemic attack within the last 6 months 7. There are active infections (such as viral, bacterial or fungal infections) that require systemic treatment/there are any active infections at the time of screening, including but not limited to urinary tract infections, respiratory infections, diabetic foot infections, etc. 8. The study received colony-stimulating factor, erythropoietin and other treatments within 2 weeks before medication. 9. Previous treatment with bone marrow transplant, stem cell transplant or organ transplant. 10. irAE grade = 3 after immunotherapy. 11. Have a history of previous vaccine allergy, or have received live attenuated vaccine within 4 weeks prior to enrollment or plan to receive live attenuated vaccine during the study period. 12. Patients who had been treated with systemic immunosuppressive drugs or immunostimulatory drugs within 2 weeks before enrollment. 13. People with a history of immunodeficiency. 14. Long-term use of drugs that interfere with the assessment of toxicity or immune activity associated with the investigational drug (such as > 10 mg/ day prednisone or equivalent dose therapy). 15. A known history of prior allergy to test drug components or related ingredients. 16. Hepatitis B Surface antigen (HBsAg) positive and HBV DNA copy number > during screening; Test unit normal value, hepatitis C antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Effectiveness (objective response rate, ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;Disease Control Rate, DCR; | — |
Countries
China
Contacts
Public ContactJunchao Guo
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed