pancreatic cancer
Conditions
Interventions
Case series:using SOXIRI program
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study, signed informed consent, and followed up; 2. Aged 18-75 years old male and female; 3. Pancreatic ductal cell carcinoma confirmed by histopathological examination; 4. Patients who are not surgically resectable or recurrent, require (1) Non-surgical resection definition: laparotomy can not be surgically removed, or imaging examination shows extra-pancreatic lesions, superior mesenteric artery or celiac artery involvement and MDT discussion can not be surgically removed; (2) Have not received any palliative chemotherapy (new or adjuvant chemotherapy has been discontinued for more than half a year and has not been treated with oxaliplatin and irinotecan); (3) palliative radiotherapy end = 3 months, and recurrent metastases are non-radiotherapy lesions; 5. According to the RECIST 1.1 standard, at least one measurable lesion, CT scan =10mm; clinical routine examination instrument = 10mm, chest X-ray = 20mm; malignant lymph node: pathologically enlarged and measurable, single lymph node CT scan short diameter = 15mm (CT scanning layer thickness is not more than 5mm); 6. ECOG system status score is 0~1; 7. The organ function is basically normal, that is, it meets the following criteria: (1) Absolute neutrophil count = 2.0 × 10^9/L (2) platelet count = 90 × 10^9/L (3) hemoglobin = 90g/L; (4) AST (SGOT) and ALT (SGPT) = 2.5 times the upper limit of normal. AST (SGOT) and ALT (SGPT) = 5 times normal upper limit for patients with liver metastases; (5) Total bilirubin = 1.2 × UNL, or biliary stent placement and drainage = 3.0 × UNL; (6) creatinine = 1.25 times the upper limit of normal (ULN); (7) Estimated creatinine clearance = 60 mL / min (Cockcroft-Gault formula); 8. Life expectancy = 3 months from the time of the first dose planned; 9. The subject received radiation or surgery for = 4 weeks and the wound was completely healed; 10. No history of other malignant tumors (except for cervical cancer in situ, basal and squamous cell carcinoma of the skin); 11. Women of childbearing age are required to undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. Males should be surgically sterilized, or consent to appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1. The investigator determined that the patient was not eligible for the study, including (but not limited to): (1) other malignant tumors have occurred in the past 5 years, except for appropriately treated cervical carcinoma in situ or non-melanoma skin cancer; (2) symptomatic brain metastases (already confirmed or suspected); (3) myocardial infarction, severe unstable angina, congestive heart failure in the past 6 months; (4) People with high blood pressure who cannot be reduced to normal range with antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); (5) serious complications, including intestinal paralysis, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis; (6) Chronic nausea, vomiting or diarrhea (more than or equal to 4 times a day, or watery stools); (7) gastrointestinal bleeding, need frequent blood transfusion; (8) known to carry human immunodeficiency virus (HIV) or have AIDS (AIDS); (9) suffering from mental illness; (10) known neuropathy with a severity of 2 or higher; (11) infectious diseases or uncontrollable active infections, body temperature = 38 degree C; 2. A variety of factors that affect the absorption of oral drugs such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction; 3. Known to be allergic to any drug in the study; 4. Being used or participating in other drug clinical trials within 4 weeks; 5. According to the investigator's judgment, there are accompanying diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival;disease control rate;safety;quality of Life; | — |
Countries
China
Contacts
Public ContactGuifang Guo
Sun Yat-sen University Cancer Center
Outcome results
None listed