pancreatic cancer
Conditions
Interventions
Treatment group:Albumin-bound paclitaxel + gemcitabine + statins
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, regardless of gender. 2. Histologically or cytologically confirmed pancreatic adenocarcinoma, radiologically assessed as resectable or borderline resectable pancreatic cancer. Borderline resectable is defined as: (1) Tumor contact with the portal vein–superior mesenteric vein >180°, or contact 4 weeks; considered suitable by the investigator for concomitant use of statins (e.g., atorvastatin, simvastatin, etc.) during chemotherapy. 5. Expected survival >=12 weeks. 6. Performance status: ECOG =3.0×10?/L; ANC >=1.5×10?/L; PLT >=100×10?/L; HGB >=90 g/L. (2) Liver function: AST =60 mL/min. (4) Coagulation function: INR <=1.5, APTT <=1.5×ULN. (5) Electrocardiogram and echocardiogram without significant abnormalities; good cardiac function prior to enrollment; no myocardial infarction within 6 months; hypertension and other coronary heart diseases currently under control. 10. No other uncontrollable benign diseases such as pulmonary, renal, or hepatic infections prior to enrollment. 11. Women of childbearing potential must have a negative serum pregnancy test within 3 days before initiating treatment and must be willing to use appropriate contraceptive methods during the study period and for 6 months after the end of treatment. For males, they must be surgically sterilized or agree to use appropriate contraceptive methods during the study period and for 3 months after the end of treatment. 12. Subjects voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Imaging and clinical assessment indicating severe biliary obstruction or gastrointestinal obstruction with jaundice. 2. Severe weight loss (e.g., >10% within 6 months or >5% within 1 month, accompanied by extreme anorexia) or cachexia with a PG-SGA score of C. 3. Severe hypoalbuminemia (e.g., ALB 10 mg/day) or who have used immunosuppressive drugs within 14 days prior to the first dose (subjects without active autoimmune disease using inhaled or topical corticosteroids, or prednisone >10 mg/day for adrenal insufficiency replacement therapy, may be enrolled); (3) Subjects who have received tumor vaccines or other immune-stimulatory antineoplastic agents (e.g., interferons, interleukins, thymosin, or immune cell therapy) within 1 month prior to the first dose; (4) Subjects currently participating in other clinical trials; (5) Subjects with other malignancies requiring treatment (subjects with definitively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, breast carcinoma in situ, or cervical carcinoma in situ who require no further treatment may be enrolled); (6) Subjects with a history of severe cardiovascular disease: Grade >=2 myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >=480 ms); Grade III–IV cardiac insufficiency; echocardiography indicating left ventricular ejection fraction (LVEF) =2+, etc.). 6. Known allergy or hypersensitivity to any of the other drugs in the treatment regimen. 7. Subjects with mental illness, alcohol abuse, drug abuse, or similar conditions should be excluded. 8. Pregnant or breastfeeding women. 9. Conditions that, in the investigator's opinion, make the subject unsuitable for enrollment, including diseases or laboratory abnormalities that may affect study results or are not in the subject's best interest, should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Surgical resection rate;Node-negative resection;Disease control rate;Duration of response;Progression-free survival;Overall Survival;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactJiao Zuoyi
Lanzhou University Second Hospital
Outcome results
None listed