advanced pancreatic cancer
Conditions
Interventions
test group:Fluzoparib + oxaliplatin
Sponsors
First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a. Pancreatic ductal adenocarcinoma proved histologically or cytologically, pancreatic neuroendocrine tumor, pancreatic lymphoma, or ampulla carcinoma did not meet the inclusion criteria. b. Age 18-75 years old, gender unlimited. c. Expected survival =3 months. D.cog is rated 0-1. e. Have at least 1 measurable lesion according to RECIST1.1. f. Evidence of radiographic or clinical disease progression from previous second-line or higher standard care. g. Have not previously received platinum-based chemotherapy, including but not limited to cisplatin, carboplatin, oxaliplatin; Or have received platinum-based chemotherapy, and it is more than 6 months since the last platinum treatment. h. have not been previously treated with PARP inhibitors, including but not limited to Viripalil, olapalil, Nilapalil, Lucapalil, talazopalil, and fluzopalil. i. Allow the use of immune checkpoint inhibitors in front-line therapy to continue across lines. j. The major organs function well, that is, the relevant examination indicators within 14 days before enrollment meet the following requirements: Hemoglobin = 90 g/L (no transfusion within 14 days); Neutrophil count > 1.5×109/L; Platelet count = 100×109/L; Total bilirubin = 1.5×ULN (upper limit of normal); If there is liver metastasis, total bilirubin =3×ULN; Serum glutamic pyruvic aminotransferase (ALT) or serum glutamic oxalacetic aminotransferase (AST) = 2.5×ULN; If there is liver metastasis, ALT or AST = 5×ULN; Endogenous creatinine clearance = 60 ml/min (Cockcroft-Gault formula); Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = 50%. k. Sign the informed consent and comply well, and the family members agree to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: a. previous or concurrent other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; Patients with small gastric stromal tumor and other tumors, as well as other early tumors after radical treatment, and other tumors that do not affect the patient's life in the short term according to the investigator's judgment can be excluded. b. At least 14 days have passed since all previous anticancer treatment; At least 28 days must have passed since any previous antibody-based therapy; A minimum of 28 days had to have elapsed since any previous trial medication. c. Patients with known CNS metastases or a history of CNS metastases prior to screening. Patients with clinically suspected CNS metastases had to undergo CT or MRI within 28 days before enrollment to rule out CNS metastases or to have stable brain metastases for more than 3 months. d. A history of unstable angina pectoris; Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmias (including QTcF =450 ms in men and =470 ms in women) required long-term use of antiarrhythmic drugs and New York Heart Association class =II cardiac dysfunction. e. Urine routine test showed urinary protein =++ and confirmed 24-hour urinary protein quantification > 1.0 g. f. For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests had to be negative within 7 days prior to study enrollment, and they had to be nonlactating. Male subjects: Patients who should be surgically sterilized, or who agree to use a medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period. g. A history of immunodeficiency or other acquired or congenital immunodeficiency disease, or a history of organ transplantation. h. Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, and other patients requiring corticosteroids. i. a history of chronic autoimmune diseases such as systemic lupus erythematosus; He had a history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease, and a history of chronic diarrhea such as irritable bowel syndrome. A history of sarcoidosis or tuberculosis; Patients with a history of active hepatitis B or C, and HIV infection. j. Patients with hypersensitivity to human or murine monoclonal antibodies. k. Persons with a history of psychotropic drug abuse and inability to quit or mental disorders. l. Pleural or peritoneal effusions with clinical symptoms requiring clinical intervention. m. Concomitant diseases that, in the judgment of the investigator, seriously compromise patient safety or prevent the patient from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progressives free survival;overall survival;6 months progression free survival rate;6 months overall survival rate;12 months progression free survival rate;12 months overall survival rate;disease control rate;quality of life;PG-SGA; | — |
Countries
China
Contacts
Public ContactWei Li
First Affiliated Hospital of Soochow University
Outcome results
None listed