A Prospective Clinical Trial of Statin Addition to Chemotherapy for Advanced Pancreatic Cancer
Trial ID: NCT06241352
Interventional - Phase 2 - Completed
The results of previous studies conducted by our team have revealed that the use of statins can more effectively hinder the growth of drug-resistant pancreatic cancer cells. The primary objective of this study was to investigate the role of statins in treating pancreatic cancer by assessing the safety and therapeutic impact of combining chemotherapy with statins in patients with advanced pancreatic cancer.
Conditions
Advanced Pancreatic Cancer
Interventions
statin addition to chemotherapy
Eligibility
Inclusion criteria
# Inclusion Criteria:
* Age≥18 years old and ≤80 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
* Histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma.
* Imaging studies confirmed the diagnosis of locally advanced or metastatic pancreatic cancer patients.
* The patients were in the plateau stage after chemotherapy, as indicated by the CA19-9 values (with CA19-9 negative patients referenced against CEA or CA-125) fluctuating by less than 20% over an interval of more than 3 weeks.
* Life expectancy of greater than 90 days, as judged by the investigator.
* Normal liver function: serum total bilirubin≤2.0mg/dl, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<3 times of the upper limit of normal value.
* Normal kidney function: serum creatinine\<1.5 times of the upper limit of normal value or creatinine clearance rate\>45ml/min.
* No severe comorbidities.
Exclusion criteria
# Exclusion Criteria:
* Patients with poor condition can not tolerate chemotherapy.
* Patients who have previously taken lipid-lowering drugs (such as statins, fibrates, ezetimibe, or PCSK9 inhibitors).
* Patients who are taking warfarin, verapamil, clopidogrel, digoxin, amiodarone, etc.
* Impaired organ functions: heart failure (New York Heart Association III- IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure.
* Patients diagnosed with other cancer within 5 years.
* Patients who are pregnant or breastfeeding.
* Patients enrolled in other clinical trials or incompliant of regular follow up.
* Patients who did not provide an informed consent.