Patients with pancreatic ductal adenocarcinoma confirmed by histological or cytological examination and locally advanced or metastatic pancreatic cancer that is unresectable as confirmed by imaging studies
Conditions
Interventions
Experimental group:The Rilafupa and Apatinib combined with AG regimen
Sponsors
The first hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, any gender; 2. Patients with pancreatic ductal adenocarcinoma confirmed by histology or cytology and confirmed by imaging as unresectable locally advanced or metastatic pancreatic cancer; 3. No prior systemic anti-tumor treatment (including chemotherapy, targeted therapy, immunotherapy, etc.) or investigational drug treatment; if previously received neoadjuvant or adjuvant therapy, the interval between the last dose and recurrence/progression must exceed 6 months, and all previous treatment-related toxicities must have recovered (graded 3 months; 6. According to the investigator's assessment based on RECIST 1.1, at least one measurable lesion; 7. Major organ function is normal and meets the following criteria: (1) Blood cell analysis: absolute neutrophil count >=1.5×10^9/L; platelets >=100×10^9/L; hemoglobin >=90 g/L; (2) Renal function: serum creatinine =50 mL/min; (3) Liver function: bilirubin =28 g/L; (4) International normalized ratio and activated partial thromboplastin time <=1.5×ULN (only for patients not receiving anticoagulant therapy; patients receiving anticoagulant therapy should have coagulation indices within the therapeutic range); (5) Thyroid-stimulating hormone <=ULN, if abnormal, T3 and T4 levels must be normal to be eligible; 8. Women of childbearing potential must agree to use contraception during the study and for 6 months after the study (such as intrauterine device, contraceptive pills, or condoms); negative serum or urine pregnancy test within 1 week before study enrollment, and must not be breastfeeding; men must agree to use contraception during the study and for 6 months after study completion; 9. Participants voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with immune checkpoint inhibitors; 2. Known allergy to the investigational drug or any of its excipients; 3. Major surgery, incisional biopsy, or significant traumatic injury within 4 weeks prior to randomization; 4. Participation in another investigational drug clinical trial within the past 4 weeks; 5. History of other malignancies within the past 5 years, except for malignancies that have been cured; 6. Presence of active autoimmune diseases or immunodeficiency diseases, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc., which are not eligible. Exceptions: participants whose disease is stable and do not require systemic immunosuppressants, such as type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, or skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or participants with no expected recurrence without external triggers may participate in this study; 7. History of substance abuse involving psychiatric medications that cannot be discontinued or presence of psychiatric disorders; 8. Presence of any severe and/or uncontrolled disease: (1) Patients with poorly controlled blood pressure (systolic >=150 mmHg or diastolic >=100 mmHg); (2) Presence of clinically significant severe cardiovascular disease: clinically significant severe cardiovascular events occurring within 6 months before randomization, such as myocardial infarction, unstable angina, symptomatic congestive heart failure (NYHA Class III or IV), severe arrhythmias requiring medication or undergoing angioplasty, stent implantation, or coronary artery bypass grafting. Echocardiography indicating left ventricular ejection fraction (LVEF) 470 ms) or family history of QT interval prolongation; (3) Poorly controlled diabetes (fasting blood glucose FBG>10 mmol/L); (4) Exacerbation of chronic obstructive pulmonary disease or other severe respiratory diseases requiring hospitalization; (5) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; (6) Decompensated cirrhosis, active hepatitis, or chronic hepatitis requiring antiviral treatment; (7) Renal dysfunction: urinalysis showing proteinuria >=++, and 24-hour urinary protein quantification >=1.0 g; 9. Severe infection within 4 weeks before first dose (including but not limited to infectious complications, bacteremia, severe pneumonia requiring hospitalization; requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever >=38.5°C during screening/ before first dose; 10. Presence of active brain metastases or meningeal metastases at enrollment; 11. Presence of acute pancreatitis or recent subclinical pancreatitis requiring intervention (meeting any 2 of the following criteria): 1) acute, sudden, and persistent abdominal pain; 2) serum amylase and/or lipase >3×ULN; 3) imaging (CT/MRI) showing typical changes of acute/chronic pancreatitis (pancreatic edema, pancreatic or peripancreatic inflammatory changes, pancreatic necrosis); 12. According to the investigator's judgment, if the patient is unlikely to comply with study procedures, restrictions, and requirements, they cannot participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactYusheng Wang
The first hospital of Shanxi Medical University
Outcome results
None listed