Pancreatic cancer
Conditions
Interventions
BRCA mutation group:Fluzoparib
Non-BRCA mutation group and undetected group:Fluzoparidi combined with capecitabine
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-65, male and female, non-limited; 2. Histologically or cytologically confirmed recurrent or metastatic inoperable pancreatic ductal adenocarcinoma; 3. Patients with platinum-containing chemotherapy regimen at least 16 weeks in the front line, and the disease has not progressed, locally advanced inoperable or metastatic pancreatic cancer; 4. Patients with disease that are clearly unresectable according to anatomical standards determined by multidisciplinary teams, are considered candidates for chemotherapy treatment; 5. According to RECIST 1.1 standard, there are measurable lesions at baseline; 6. ECOG PS: 0-1; 7. Expected survival time >3 months; 8. No previous treatment with PARP inhibitors 9. The main organs have good function and meet the following criteria: a) Routine blood test (without transfusion within 14 days and no correction of hematopoietic stimulator drugs): hemoglobin (Hb) >= 90g/L; absolute neutrophil count (ANC) >= 1.5×10^9/L; platelets (PLT) >= 90×10^9/L; b) Biochemical test: alanine aminotransferase (ALT) and alanine aminotransferase (AST) = 60mL/min; c) Coagulation function: activated partial thromboplastin time (APTT), international standardized ratio (INR), prothrombin time (PT) = 2+, 24-hour urinary protein quantification should be = 50%. 10. Women of childbearing age should agree to adopt contraceptive measures (such as IUDs, cont 11. The subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who participated in other clinical trials at the same time; 2. Past allergic reactions, hypersensitivity, and intolerance to similar drugs; previous allergies to drugs or foods or other substances; 3. Patients with lack of physical integrity in the gastrointestinal tract, resulting in malabsorption syndrome or intestinal obstruction, affecting the administration and absorption of oral treatment; 4. Patients with known DPD (dihydropyrimidine dehydrogenase) deficiency; 5. Use known CYP 3A 4 inhibitor/CYP 3A 4 inducer; 6. Treatment of blood transfusion within 1 month before the start of the trial; 7. Patients with myelodysplastic syndrome/acute myeloid leukemia; 8. undergo major surgery within 14 days after the start of the trial treatment, and patients must recover from any impact of major surgery; 9. Patients with previous non-hematologic toxicity of capecitabine-related grade III/IV, except for hair loss or nausea and vomiting, unless it is not controlled after the maximum dose of antiemetic support; 10. Patients who have previously been unable to tolerate standard doses of capecitabine; 11. Patients with uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; known history of HIV infection or AIDS; active syphilis; active tuberculosis; active infection; uncontrolled hypertension, symptomatic cardiac insufficiency; active bleeding; 12. A clear history of mental disorders (including epilepsy or dementia); or other circumstances that the investigator believes are not suitable for participation in the study; 13. Patients who believe that it is unlikely to comply with the study steps, restrictions and requirements shall not participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective Response Rate;6 months PFS rate;6 months PFS rate;12-month PFS rate;12 months OS rate;Quality of life score;Nutritional Score PG-SGA; | — |
Countries
China
Contacts
Public ContactHe Wei
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed