Statin Addition to Chemotherapy for Advanced Pancreatic Cancer

Trial Title: Statin Addition to Chemotherapy for Advanced Pancreatic Cancer

NCT ID: NCT06241352

Condition: Advanced Pancreatic Cancer

Conditions: Official terms:
Pancreatic Neoplasms

Conditions: Keywords:
advanced pancreatic cancer
statin
chemotherapy resistance

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: statin addition to chemotherapy
Description: Chemotherapy was administered along with 80mg of atorvastatin per day. Atorvastatin was discontinued when CA19-9 levels (with CA19-9 negative patients referenced against CEA or CA-125) rose more than 20% above baseline.
Arm group label: Statin addition to chemotherapy

Summary: 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.

Detailed description: The poor prognosis of pancreatic cancer is not just because of the high malignancy of the tumor itself, but also its poor response to chemotherapy. Gemcitabine and fluorouracil are the primary drugs utilized in pancreatic cancer treatment, and combination chemotherapy predominantly revolves around these two drugs. Nevertheless, findings from clinical studies reveal that approximately one-third of pancreatic cancer patients display resistance to chemotherapy, with the majority of the remaining patients eventually developing secondary resistance within six months following treatment. Consequently, chemotherapy resistance constitutes a significant factor contributing to the poor prognosis of pancreatic cancer patients. Our research team established a biobank containing over 300 pancreatic cancer organoids. Using high-throughput drug sensitivity detection techniques, the investigators assessed the sensitivity of 177 pancreatic cancer organoids to five commonly used chemotherapeutics and 84 tumor-related drugs or regimens. The findings suggest that pancreatic cancer organoids that are generally resistant to chemotherapy drugs exhibit sensitivity to statins. These findings indicate that combining chemotherapy with statins may enhance the therapeutic effect for pancreatic cancer patients. Previous studies have also reported the potential therapeutic effects of statins in colorectal, lung and breast cancer. In summary, chemotherapy resistance is a significant factor contributing to the poor prognosis of pancreatic cancer. Building on previous research conducted by our team, this study aims to investigate the role of statins in pancreatic cancer through a single-arm clinical trial, with the goal to investigate the role of statins in treating pancreatic cancer.

Criteria for eligibility:
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. - Routine blood test: absolute neutrophil count>1500/mm3, platelet>100000/ mm3. - 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: - 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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Changhai Hospital

Address:
City: Shanghai
Zip: 200433
Country: China

Status: Recruiting

Contact:
Last name: Shiwei Guo, MD

Phone: +8618621500666
Email: gestwa@163.com

Contact backup:
Last name: Huan Wang, MD

Phone: +8613162712127
Email: mr_wang_huan@163.com

Start date: January 20, 2024

Completion date: February 2027

Lead sponsor:
Agency: Changhai Hospital
Agency class: Other

Source: Changhai Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06241352