Pancreatitc cancer
Conditions
Interventions
Test group:Sofantinib combined with albumin bound paclitaxel and gemcitabine hydrochloride
Sponsors
First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pathological diagnosis is pancreatic adenocarcinoma; 2.The patient is initially treated or relapsed locally advanced pancreatic adenocarcinoma; 3.The maximum size of tumor should be no more than 10 cm; 4.ECOG score is 0-1; 5.The expected survival time is greater than 6 months; 6.Patients who received chemotherapy for malignancies other than pancreatic cancer more than 5 years ago were also eligible for this study, the chemotherapy should be administered 5 years ago and there is no evidence of a second malignancy at study enrollment; 7.The absolute neutrophil count (ANC) must be greater than or equal to 1500/uL; 8.A radiographically evaluable disease is needed; 9.Platelet count should be =100,000/uL; serum creatinine must be =2.0 mg/dL, total bilirubin =2.0 mg/dL in the absence of biliary obstruction; biliary decompression is required when biliary obstruction exists; endoscopic biliary stents or percutaneous transhepatic drainage were acceptable; once biliary drainage is established, regimen therapy can be initiated when total bilirubin drops to 4.0 mg/dL or lower; 10.The creatinine clearance must be =35; 11.Patients must understand their disease, written informed consent should be signed after being informed of the procedures to be followed.
Exclusion criteria
Exclusion criteria: 1.Unable to comply with the study protocol or procedure; 2.Used to receive the treatment of vascular endothelial growth factor receptor (VEGFR) inhibitors or immune checkpoint inhibitors 3.Patients who are articipating or participated in other clinical trials of other drugs within 4 weeks; 4.Patients who received brachytherapy (particle implantation) within 60 days; 5.Patients who received other systemic antitumor therapies, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy, within 4 weeks; 6.Patients who received any surgery or invasive treatment or operation (except intravenous catheterization, puncture drainage, etc.) within 4 weeks; 7.Patients who received major surgical operations within 60 days or surgical incisions were not completely healed; 8.Patients who received local anti-tumor therapy, such as hepatic arterial interventional embolization, liver metastasis cryoablation or radiofrequency ablation within 4 weeks; 9.The patient has medically uncontrolled hypertension, which is defined as: systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 10.Urine routine indicated urine protein =2+, or 24 hours urine protein =1.0g; 11.Investigator identified clinical significant electrolyte abnormalities; 12.Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure above Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (left ventricular ejection fraction) less than 50%; 13.Bleeding events = grade 3 occurred 4 weeks before enrollment; 14.Patients with significant evidence or history of bleeding tendency within 3 months (bleeding within 3 months for more than 30 mL, hematemesis, black feces, hematochezia), hemoptysis (more than 5 mL fresh blood within 4 weeks ) or a thromboembolic event (including stroke and/or transient ischemic attack) within 12 months; 15.International Normalized Ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5×ULN, or the patient is taking anticoagulants; 16.The patient currently has poorly controlled diabetes mellitus (fasting glucose concentration =CTCAE level 2 after formal treatment); 17.The patient has any disease or condition that affects drug absorption, or the patient is unable to take sofentinib orally; 18.Active or uncontrolled severe infection (=CTCAE grade 2 infection); 19.A known history of clinically significant liver disease, including viral hepatitis [Active HBV infection must be excluded as a known carrier of hepatitis B virus (HBV), i.e. positive HBV DNA (>1×104 copies /mL or > 2000 IU/ml); known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis; 20.The patient currently has active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding from unexcised tumors, or other conditions that researchers have determined may cause gastrointestinal bleeding or perforation; 21.Unmitigated toxicity higher than CTCAE grade 1 due to any previous anticancer therapy, excluding hair loss and neurotoxicity less than grade 2 caused by oxaliplatin; 22.Allergy or suspected allergy to sofentinib or similar drugs; 23.23. Women who are pregnant (positive pregnancy test before med
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion rate;Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 removal rate;Local or distant recurrence rate after resection of R0 or R1;Disease free survival after R0 or R1 resection;Overall survival, OS;safety; | — |
Countries
China
Contacts
Public ContactZheng Wang
First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed