Pancreatic cancer
Conditions
Interventions
Intervention group:Fluzopalil
Sponsors
The First People's Hospital of Changzhou
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-79 years old; 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 points and expected survival >=6 months. 3. Histologically or cytologically confirmed pancreatic adenocarcinoma; 4. Inoperable assessed by at least two hepatobiliary surgeons; 5. At least two radiotherapy experts evaluate the radiotherapy: inoperable locally advanced pancreatic cancer is still evaluated after neoadjuvant chemotherapy; Pancreatic cancer that cannot tolerate systemic intravenous chemotherapy; oligometastatic pancreatic cancer with good response or slow progression after chemotherapy; Other pancreatic cancers that have been evaluated by radiotherapy experts and considered to be radiotherapy; 6. Presence of at least one measurable lesion meeting RECIST criteria; 7. No serious hematopoietic function, heart, lung, liver, and kidney function abnormalities in the past; 8. Ability to understand and willing to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Patients who have received abdominal radiotherapy prior to study entry. 2. Radiotherapy only irradiates patients with metastases. 3. Patients treated with prior treatment with a poly-ADP-ribose polymerase (PARP) inhibitor. 3. Patients who are allergic to any of the study ingredients. 4. Treatment of patients with CYP4A3 inducers within weeks or inhibitors within 2 weeks. 5. Significant cardiovascular disease, such as New York Cardiac Grade III/IV, heart failure, myocardial infarction, unstable cardiac arrhythmia, or evidence of ECG ischemia within 6 months prior to enrollment. 6. Patients who are unable to swallow oral medications and patients with gastrointestinal disorders that may interfere with the absorption of study medications. 7. Patients with myelodysplastic syndrome/acute myeloid leukemia. 8. Patients with second primary cancer, unless the first primary is curative carcinoma in situ or slowly progressive malignant tumor. 9. Known active hepatitis B or C infection. 10. History of immunodeficiency (including HIV infection) or organ transplantation. 11. Pregnant or lactating women. 12. Patients with dihydropyrimidine dehydrogenase (DPD) deficiency. 13. Other serious concomitant diseases that, in the opinion of the investigators, may have a significant adverse effect on the safety of the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival,PFS;Disease control rate,DCR;Overall survival,OS;Incidence of treatment-related toxic reactions; | — |
Countries
China
Contacts
Public ContactGu Wendong
The first people‘s hospital of Changzhou/The third affiliated of Soochow university
Outcome results
None listed