pancreatic cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 2. Age: >= 18 years old, male or female; 3. Pancreatic cancer diagnosed by pathology or imaging with measurable lesions; 4. ECOGPS: 0-2 points; 5. The main organ functions are normal and meet the following requirements: (1) Blood routine examination must meet the following requirements (no blood transfusion within 14 days): 1) Hemoglobin >= 90 g/L; 2) Neutrophil (ANC) >= 1.5 x 10^9/L; 3) Platelet >= 100 x 10^9/L; (2) Biochemical examination must meet the following standards: 1) Bilirubin = 50 ml/min (Cockcroft-Gault formula); 6. Expected survival period >= 3 months; 7. The investigator judges that the patient can receive treatment with fluzoparib or fluzoparib combined with radiotherapy; 8. Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last dose; for men, they should be surgically sterilized , or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last dose.
Exclusion criteria
Exclusion criteria: 1. Subjects with severe liver and kidney damage, Severe hepatorenal insufficiency; 2. Those who have been proved to be allergic to fluzoparib or combination drugs and/or their excipients; 3. There are serious factors that affect the oral and absorption of drugs; 4. Patients with severe ascites and pleural effusion with clinical symptoms who need puncture and drainage; 5. Patients with active tuberculosis infection; 6. Patients with uncontrollable blood diseases, severe anemia, severe decrease in leukocytes, neutrophils, lymphocytes or platelets; 7. Any condition that may damage patient safety or integrity of research data, including serious medical risk factors, physical conditions, laboratory abnormalities; 8. Pregnant or lactating women; 9. Patients with a history of psychotropic substance abuse who cannot be abstained from or who have mental disorders; 10. The patient is participating in any trial with an intervention outside of routine clinical practice; 11. Other patients judged by the investigator to be unsuitable for inclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (Objective response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS (Progression-free survival);DCR (Disease control rate);6-month overall survival rate;12-month overall survival rate;Safety; | — |
Countries
China
Contacts
Harbin Medical University Cancer Hospital