advanced pancreatic cancer
Conditions
Interventions
1:chidamide+anti-PD-(L)1+gemcitabine-based chemotherapy
Sponsors
the First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed pancreatic cancer; 2. Aged 18 to 75 years, with no gender limitation; 3. Estimated survival >= 3 months; 4. ECOG score 0-1; 5. Have at least one measurable lesion according to RECIST 1.1; 6. No previous chemotherapy, radiotherapy, immunotherapy, or targeted therapy. 7. Good function of major organs, that is, relevant examination indexes within 14 days before enrollment meet the following requirements: (1) Hemoglobin >= 90 g/L (no blood transfusion within 14 days); (2) Neutrophil count & GT > 1.5 x 10^9 / L; (3) Platelet count >= 100×10^9/L; (4) Total bilirubin = 60 mL /min (Cockcroft-Gault formula); (7) Cardiac Doppler ultrasonography: Left ventricular ejection fraction (LVEF) >= 50%; 8. Informed consent was signed with good compliance, and family members agreed to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Past or concurrent malignancy, other than cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; Patients with small gastric stromal tumors and other early tumors can be excluded after radical treatment, other tumors that the researchers judge will not affect the patient's life in the short term; 2. Participated in clinical trials of other drugs within four weeks; 3. Screening of patients with known CNS metastasis or a history of CNS metastasis. For clinically suspected patients with CNS metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude CNS metastasis; 4. Patients with a history of unstable angina pectoris; Patients who were newly diagnosed with angina pectoris within 3 months before screening or had myocardial infarction within 6 months before screening; Arrhythmias (including QTcF: >= 450 ms for men and >= 470 ms for women) requiring long-term use of antiarrhythmic drugs and New York Heart Association classification >= II cardiac insufficiency; 5. Urine routine indicated urine protein >= ++ and confirmed 24-hour urine protein quantification & GT; 1.0 g; 6. For female subjects: surgically sterilized, postmenopausal, or have consented to use a medically approved contraceptive during study treatment and for 6 months after the study treatment period; Serum or urine pregnancy tests must be negative during the 7 days prior to study enrollment and must be non-lactation. Male subjects: patients who are surgically sterilized or who have agreed to use a medically approved contraceptive during and for 6 months after the study treatment period; 7. Prior use of immunotargeted therapy drugs; 8. A history of immunodeficiency, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation; 9. Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids; 10.History of chronic autoimmune diseases, such as systemic lupus erythematosus; A history of ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases, and a history of chronic diarrheal diseases such as irritable bowel syndrome; A history of sarcoidosis or tuberculosis; Patients with active history of hepatitis B and C and HIV infection; 11.Patients with hypersensitivity to human or mouse monoclonal antibodies; 12.Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 13.Pleural or abdominal effusion with clinical symptoms requiring clinical intervention; 14.Concomitant diseases that, according to the investigator's judgment, seriously endanger the patient's safety or affect the patient's ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progressives free survival, PFS;Overall survival, OS;6 months PFS rate;6 months OS rate;12 months PFS rate;12 months OS rate;Disease Control Rate, DCR;Quality of Life; | — |
Countries
China
Contacts
Public ContactLi Wei
the First Affiliated Hospital of Soochow University
Outcome results
None listed