advanced pancreatic cancer
Conditions
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be enrolled in this study, patients must meet all of the following criteria: 1. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up; 2. Advanced or metastatic pancreatic cancer confirmed by histopathology or cytology; 3. Aged 18-75 years old (including 18 and 75 years old), male or female; 4. ECOG performance status: 0-1; 5. Expected survival =3 months; 6. No prior systematic treatment for advanced pancreatic cancer; 7. At least one measurable lesion was required. (Response evaluation criteria in Solid Tumors, RECIST, version 1.1) 8. No serious organic diseases of heart, lung, brain and other organs; 9. The main organs and bone marrow functions are basically normal: Blood routine: leukocyte = 4.0 x 10?/L, neutrophils = 1.5 x 10?/L, platelets = 80 x 10?/L, hemoglobin = 90g/L; International standardized ratio (INR) =1.5× upper limit of normal (ULN), and activated partial thromboplastin time (APTT) =6s; Liver function: serum total bilirubin = 1.5 x ULN; ALT/AST = 3 x ULN; Renal function: serum creatinine = 1.5 x ULN, creatinine clearance (CCr) = 50mL/min; 10. Male and premenopausal female patients: consent to use a medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period. The female patient was not lactating and had a negative blood or urine pregnancy test within 7 days prior to enrollment.
Exclusion criteria
Exclusion criteria: Patients will not be admitted to the study if they meet any of the following criteria: 1. Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment; 2. Previous targeted therapy or previous immune checkpoint inhibitor therapy; 3. Central nervous system (CNS) metastases or previous brain metastases; 4. Received any surgery (except biopsy) or invasive treatment or operation within 4 weeks prior to enrollment, and the surgical incision was not completely healed (except intravenous catheterization, puncture drainage, etc.); 5. The patient currently has high blood pressure that cannot be controlled by drugs, which is defined as: systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 6. Patients with obvious evidence of bleeding tendency or history within 3 months before enrollment (hemorrhage >30 mL within 3 months, hematemesis, stool, and blood in the stool), hemoptysis (fresh blood >5 mL within 4 weeks); Patients with a history of inherited or acquired bleeding or coagulation disorders. There were clinically significant bleeding symptoms or definite bleeding tendencies within 3 months prior to randomization, such as gastrointestinal bleeding and hemorrhagic gastric ulcer; 7. Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; 8. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure New York Heart Association (NYHA) Grade >2; Ventricular arrhythmias requiring medical treatment; Electrocardiogram (ECG) showed QT c interval =480 ms; 9. Active or uncontrolled severe infection (=CTCAE v5.0 grade 2 infection); 10. Known human immunodeficiency virus (HIV) infection. A known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., HBV DNA positive (>1×104 copies /mL or >2000 IU/ml) must be excluded; known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL) must be excluded;] 11. Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade =2 neurotoxicity; 12. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 13. Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 14 days before enrollment; 14. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, in which, in the investigator's judgment, there is reason to suspect that the patient has a medical condition or condition that is not suitable for the investigational drug (such as having seizures and requiring treatment), or that would affect the interpretation of the study results or place the patient at high risk; 15. Urine routine indicated urinary protein =2+, and 24-hour urinary protein volume > 1.0g; 16. Complications require long-term immunosuppressive therapy, or systemic or local use of immunosuppressive corticosteroids (>10mg/ day prednisone or other therapeutic hormones); 17. The patients considered by the investigators to be unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival,PFS;overall survival,OS;disease control rate;duration of remission; | — |
Countries
China
Contacts
Public ContactJun Xue
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed