Advanced Pancreatic CancerPhase 2NCT06241352
Statin Addition to Chemotherapy for Advanced Pancreatic Cancer
A Phase 2 study testing statin addition to chemotherapy in people with Advanced Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- statin addition to chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2024to 30 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical Trial of Statin Addition to Chemotherapy for Advanced Pancreatic Cancer
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.
Read the 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.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- statin addition to chemotherapy
- Keywords
- advanced pancreatic cancer, statin, chemotherapy resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
statin addition to chemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Statin addition to chemotherapy | Experimental | Chemotherapy plus atorvastatin was used in locally advanced pancreatic cancer. Receives: Drug: statin addition to chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease rate of CA19-9 (with CA19-9 negative patients referenced against CEA or CA-125)
The proportion of patients with a decrease of over 20% in CA19-9 (with CA19-9 negative patients referenced against CEA or CA-125) one month after the start of treatment.
Measured: 1-2 month
Secondary outcomes (3)
Event-free Survival
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.
Measured: 1 year
Overall survival
Defined as the time between signing the informed consent form and death due to various causes.
Measured: 2 years
Disease control rate
Defined as the proportion of patients who achieved complete response (CR), partial response (PR) and stable disease (SD) according to RECIST v1.1.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start20 Mar 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo ShiWei, Changhai Hospital
- Investigators
- Gang Jin, MD, Principal investigator, Changhai Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241352
- Sponsor's protocol ID
- ChanghaiH-PP13
- Status last verified
- May 2025
- First submitted
- 28 Jan 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Tang S, Wang H, Zhu H, Lu Y, Zhang Y, Guo S, He J, Li Y, Zhang Y, Shi X, Miao Y, Zhong C, Zhu Y, Ju Y, Liu Y, Sun M, Wang Y, Chen L, Zhou H, Jin G, Gao D. A pancreatic cancer organoid biobank links multi-omics signatures to therapeutic response and clinical evaluation of statin combination therapy. Cell Stem Cell. 2025 Sep 4;32(9):1369-1389.e14. doi: 10.1016/j.stem.2025.07.008. Epub 2025 Aug 13.
PubMed 40812300
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial of Statin Addition to Chemotherapy for Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06241352
- Acronym / sponsor ID
- ChanghaiH-PP13
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- advanced pancreatic cancer, statin, chemotherapy resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Statin addition to chemotherapy | Experimental | Drug: statin addition to chemotherapyChemotherapy plus atorvastatin was used in locally advanced pancreatic cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| statin addition to chemotherapyChemotherapy 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. | Drug | Statin addition to chemotherapy |
Primary outcome
Decrease rate of CA19-9 (with CA19-9 negative patients referenced against CEA or CA-125)
Time frame: 1-2 month
The proportion of patients with a decrease of over 20% in CA19-9 (with CA19-9 negative patients referenced against CEA or CA-125) one month after the start of treatment.
3 secondary outcomes
Event-free Survival
Time frame: 1 year
Overall survival
Time frame: 2 years
Disease control rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 40812300Li Y, Tang S, Wang H, Zhu H, Lu Y, Zhang Y, Guo S, He J, Li Y, Zhang Y, Shi X, Miao Y, Zhong C, Zhu Y, Ju Y, Liu Y, Sun M, Wang Y, Chen L, Zhou H, Jin G, Gao D. A pancreatic cancer organoid biobank links multi-omics signatures to therapeutic response and clinical evaluation of statin combination therapy. Cell Stem Cell. 2025 Sep 4;32(9):1369-1389.e14. doi: 10.1016/j.stem.2025.07.008. Epub 2025 Aug 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Jin, MD principal investigator
Changhai Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing statin addition to chemotherapy in people with Advanced Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease rate of CA19-9 (with CA19-9 negative patients referenced against CEA or CA-125) (time frame: 1-2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06241352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.