- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06241352
Statin Addition to Chemotherapy for Advanced Pancreatic Cancer
A Prospective Clinical Trial of Statin Addition to Chemotherapy for Advanced Pancreatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Shiwei Guo, MD
- Phone Number: +8618621500666
- Email: gestwa@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Recruiting
- Changhai Hospital
-
Contact:
- Shiwei Guo, MD
- Phone Number: +8618621500666
- Email: gestwa@163.com
-
Contact:
- Huan Wang, MD
- Phone Number: +8613162712127
- Email: mr_wang_huan@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Statin addition to chemotherapy
Chemotherapy plus atorvastatin was used in locally advanced pancreatic cancer.
|
Chemotherapy was administered along with 80mg of atorvastatin per day.
Atorvastatin was discontinued when CA19-9 levels rose more than 20% above baseline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease rate of CA19-9
Time Frame: 1 month
|
The proportion of patients with CA19-9 decreased by more than 20% in one month after the start of treatment.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free Survival
Time Frame: 1 year
|
Defined as the time between signing the informed consent form to the first documentation of event where events considered are 1) disease progression (local recurrence, new lesions or distant metastasis), 2) a second malignant tumor occurs, or 3) death due to any cause.
|
1 year
|
Overall survival
Time Frame: 2 years
|
Defined as the time between signing the informed consent form and death due to various causes.
|
2 years
|
Disease control rate
Time Frame: 6 months
|
Defined as the proportion of patients who achieved complete response (CR), partial response (PR) and stable disease (SD) according to RECIST v1.1.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gang Jin, MD, Changhai Hospital, Shanghai, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChanghaiH-PP13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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