Metastatic pancreatic cancer
Conditions
Interventions
Intervention group:Personalized first-line therapeutic regimen for each patient according to the PTC drug sensitivity test results
Control group:First-line treatment regimen for each patient according to CSCO/NCCN guidelines
Sponsors
The Affliated Changzhou No. 2 People’s Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Patients with clinically suspected metastatic pancreatic cancer whose diagnoses can be confirmed by cytological or histological examinations 2: No previous history of radiotherapy or chemotherapy 3: According to RECIST 1.1, there are at least one measurable metastatic lesion and one puncture biopsy lesion, and both the measurable and the puncture lesions can be the same one 4: Age =18 years old, =75 years old, regardless of gender 5: ECOG score 0-2 6: Expected survival =3 months 7: The blood routine examination within 1 week before enrollment was basically normal (no blood transfusion or hematopoietic stimulating factor treatment within 2 weeks) : neutrophil count =1.5*109/L, hemoglobin =100g/L, platelet count =100*109/L 8: The liver and kidney function tests were basically normal within 1 week before admission (accoding to the normal values of laboratories in each research center : total bilirubin =1.5* upper limit of normal value, alanine aminotransferase =3* upper limit of normal value (for liver metastases: =5* upper limit of normal value), creatinine clearance =50ml/min 9: The coagulation function test within 1 week before enrollment was basically normal: prothrombin time PT or INR = 1.5* the upper limit of normal value, and INR was within the proposed range of anticoagulant drugs for patients receiving anticoagulant therapy 10: For patients with obstructive jaundice, ERCP or percutaneous hepatobiliary angiography (PTC) can be performed before admission.
Exclusion criteria
Exclusion criteria: 1: Other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid 2: Patients requiring elective surgery during the trial 3: Patients who are unable to swallow drugs orally or have conditions that researchers judge to seriously affect gastrointestinal absorption, such as chronic diarrhea and intestinal obstruction; 4: Pregnant (pregnancy test positive) or breastfeeding patients 5: Central nervous system metastasis or meningeal metastasis 6: Uncontrolled bone metastases, or patients at risk of fracture, requiring surgery or local radiotherapy 7: Patients with active infection requiring systemic anti-infection treatment 8: Have a history of immunodeficiency, including HIV antibody test positive patients 9: Patients with known, active autoimmune diseases 10: Uncontrolled active hepatitis B patients with hepatitis C virus infection (hepatitis C antibody positive) 11: History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe arrhythmia, acute coronary syndrome within six months, congestive heart failure, aortic dissection, stroke, TIA, etc 12: Severe bleeding events within six months, or high blood risk factors such as active gastrointestinal ulcers, cirrhosis of the esophagus and gastric varices 13: Patients with diabetes who cannot be stably controlled by medication (including insulin) 14: Patients with mental or language disorders who cannot communicate 15: Patients participating in another clinical trial at the same time 16: Patients with MSI-H/dMMR 17: According to researcher's consideration, patients with other serious systemic diseases or other conditions that are not suitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Duration of response;Success rate of establishing the PTC model; | — |
Countries
China
Contacts
Public ContactHua Jiang
The Affliated Changzhou No. 2 People’s Hospital of Nanjing Medical University
Outcome results
None listed