Recurrent or metastatic pancreatic cancer
Conditions
Interventions
experimental group:Patients will be treated with Zimberelimab combined with gemcitabine and albumin-paclitaxel. The dose of Zimberelimab was 360mg, Q3W. Gemcitabine was administrated through intraveno
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.=18 years old; 2. Patients with histologically or cytologically confirmed recurrent or metastatic pancreatic cancer who have histologically or cytologically confirmed ductal adenocarcinoma or acinar cell carcinoma. 3. No previous immunotherapy (such as PD-1/L1, CTLA-4, cellular immunotherapy, etc.); 4. Patients who have not previously been systematically treated for advanced/metastatic pancreatic cancer; Patients who had previously received neoadjuvant therapy or adjuvent therapy and developed progression more than 6 months after ending treatment. Palliative radiotherapy is permitted, but must be completed at least two weeks before starting study treatment; Previous acceptance of anti-tumor Chinese medicine preparations is permitted, but the use must be discontinued at least two weeks before the start of study treatment; 5. All toxic reactions from previous antitumor therapy or surgical procedures releved to grade 0-1 (according to NCI CTCAE version 5.0) or to the level specified in the inclusion/exclusion criteria, except hair loss, fatigue, hearing loss and other toxicities that researchers believe do not pose a safety risk to patients; 6. Measurable lesions (efficacy evaluation criteria: RECIST 1.1); The tumor should be evaluated by CT scan or MRI within 28 days prior to treatment. 7. Participants must have adequate organ function, as defined below: - Hemoglobin =9.0 g/dL - Absolute neutrophil count =1.5×109/L - Platelet count =75×109/L - Serum total bilirubin (TBIL)=1.5× upper limit of normal (ULN) (with liver aggression, =2.5×ULN) -alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN (with liver aggression, =5×ULN) -Creatinine clearance (CrCl) =60mL/min, calculated by the Cockcroft-Gault formula (using actual body weight) or measured by collected 24-hour urine. 8. Female subjects of reproductive age must have a negative serum pregnancy test result within 7 days prior to the start of the study medication and be willing to use a medically approved highly effective contraceptive (e.g., IUD, contraceptive or condom) during the study period and within 3 months after the last dose of medication is administered; Male subjects with a female partner of childbearing age should be surgically sterilized or agree to use effective contraceptive methods during the study period and within 3 months after the last study administration; 9. Participants must agree not to breastfeed during the study period and for 150 days after the last treatment. 10. Participants must be able to understand the study procedures and consent to participate in the study by providing written informed consent; 11.ECOG score 0-1 12. Life expectancy =3 months
Exclusion criteria
Exclusion criteria: 1. Use of immunosuppressive drugs within 14 days prior to medication, except nasal and inhaled corticosteroids or systemic steroid hormones at physiological doses (i.e., no more than 10 mg/ day of prednisolone or other corticosteroids at pharmacologically equivalent doses); 2. History of autoimmune disease, idiopathic pulmonary fibrosis, tissue pneumonia, drug-induced pneumonia, idiopathic pneumonia, or interstitial lung disease with active pneumonia found on chest CT scan. Active tuberculosis; 3. Lactating or pregnant women; 4. Known prior allergy to macromolecular protein preparations/monoclonal antibodies, or known allergy to any test drug component; 5. Persons who received live vaccination within 4 weeks prior to the start of treatment; 6. Those who have received anti-tumor vaccine or anti-tumor therapy with systemic immune stimulation; 7. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 8. A history of alcohol, drug or substance abuse within the last 1 year; 9. History of neurological or mental disorders, such as epilepsy, dementia, poor compliance; 10. Other severe, acute, or chronic medical conditions or laboratory abnormalities that may increase the risk of participation in the study and investigational medication, or that may interfere with the interpretation of the study results; 11. Within 6 months prior to medication, the following conditions occurred: Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, poorly controlled arrhythmias (including QTcF interphase >450 ms in men, >470 ms in women, >450 ms in women, >450 ms in men, >470 ms in women, QTcF interval calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism) 12. The participant has a known history of human immunodeficiency virus infection; 13. The investigators did not consider it appropriate for patients to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, PFS;Disease control rate, DCR;Duration of response, DoR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactJinhua Hu
Shandong Provincial Hospital
Outcome results
None listed