Ovarian CancerPhase 2NCT06468254
An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer
A Phase 2 study testing Statin and Sugar pill in people with Ovarian Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial summary
This study aims to evaluate the effect of statins combined with conventional chemotherapy and maintenance therapy on the prognosis of ovarian cancer patients, exploring its potential to improve survival rates and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Statin and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 30 Mar 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must provide written informed consent before any trial procedures commence. The consent form must be documented and retained at the research center.
- Female patients aged 18 years and older.
- Patients diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (collectively referred to as ovarian cancer) through open surgery, laparoscopic surgery, or core needle biopsy confirmed by pathology.
- Patients who will require neoadjuvant chemotherapy followed by direct surgery, or direct surgical chemotherapy.
- Liver Function:
- Total bilirubin ≤1.5 times the upper limit of normal (ULN) or direct bilirubin ≤1.0 times ULN;
Show all 9Show fewer
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN. In cases of liver metastases, AST and ALT must be ≤5 times ULN.
- Kidney Function: Serum creatinine ≤1.5 times ULN, or creatinine clearance rate ≥60 mL/min (calculated using the Cockcroft-Gault formula).
- Participants must be able to understand the trial procedures and be capable of adhering to the trial protocol for the duration of the study. This includes the ability to complete any required treatments, examinations, tests, follow-up appointments, and questionnaires associated with the trial.
Who cannot join
- Are using other investigational drugs or participating in other clinical drug trials simultaneously;
- Have used or are currently using any medications that interact with statins;
- Have active cirrhosis, uncontrolled concurrent diseases, a history of chronic myopathy, active hepatitis, or unexplained persistent elevation of serum aminotransferases;
- Are known to be allergic to statins, or any active or inactive components of drugs with similar chemical structures;
- Are unable to swallow oral medications or have any gastrointestinal disorders that might interfere with the absorption and metabolism of the study drugs, such as uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption;
- Require treatment for symptomatic or uncontrolled brain metastases, including but not limited to surgery, radiation, and/or corticosteroids, or have clinical signs of spinal cord compression;
Show all 14Show fewer
- Have severe, uncontrolled diseases or conditions that, in the investigator's judgment, make the participant unsuitable for the study. These include but are not limited to:
- Active viral infections such as HIV, hepatitis B, or hepatitis C.
- Severe cardiovascular diseases, including uncontrolled ventricular arrhythmias or a recent (within the last 3 months) myocardial infarction.
- Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorders affecting the ability to provide informed consent.
- Uncontrolled hypertension not managed by medication. Immune deficiencies (excluding splenectomy) or other conditions deemed by the investigator to pose a high risk of toxicity.
- Have any medical history or existing clinical evidence indicating the potential to confound study results, interfere with adherence to the trial protocol throughout the study, or not align with the patient's best interests;
- Have a history of or current evidence of other malignancies;
- Are pregnant, breastfeeding, or planning to become pregnant during the study period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Cancer Hospital
Hefei, Anhui, 230001
Bai-Rong Xia, MD, 18604516165, xiabairong9999@126.com
About this study
Official title: An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer: a Prospective, Multicenter Clinical Study
This study aims to evaluate the effect of statins combined with conventional chemotherapy and maintenance therapy on the prognosis of ovarian cancer patients, exploring its potential to improve survival rates and quality of life.
- Conditions
- Ovarian Cancer
- Being tested
- Statin, Sugar pill
- Keywords
- Statins
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Statin Group: Conventional chemotherapy and maintenance therapy combined with statins.
Sugar pillDrug
Control Group: Conventional chemotherapy and maintenance therapy alone.
| Study group | Role | What they receive |
|---|---|---|
| Statin Group | Experimental | Statins, 40 mg daily for 1 year or with dosage adjusted based on patient tolerance Receives: Drug: Statin |
| Control Group | Placebo comparator | Sugar pill daily for 1 year Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
The time between the start of the trial and tumor progression (in any way) or death (from any cause)
Measured: 12-month
Disease free survival
Time from surgical resection to local recurrence
Measured: 12-month
Secondary outcomes (3)
Changes of tumor marker CA125
Changes in Serum CA125 from Enrollment to End of Trial
Measured: 12-month
Changes of tumor marker HE4
Changes in Serum HE4 from Enrollment to End of Trial
Measured: 12-month
Lipid change
Changes in Serum Lipid from Enrollment to End of Trial
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bai-Rong Xia, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468254
- Sponsor's protocol ID
- 2024 NO. 049
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer: a Prospective, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06468254
- Acronym / sponsor ID
- 2024 NO. 049
- Conditions
- Ovarian Cancer
- Keywords
- Statins
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 21 Jun 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.
This study aims to evaluate the effect of statins combined with conventional chemotherapy and maintenance therapy on the prognosis of ovarian cancer patients, exploring its potential to improve survival rates and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin Group | Experimental | Drug: StatinStatins, 40 mg daily for 1 year or with dosage adjusted based on patient tolerance |
| Control Group | Placebo comparator | Drug: Sugar pillSugar pill daily for 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must provide written informed consent before any trial procedures commence. The consent form must be documented and retained at the research center.
- Female patients aged 18 years and older.
- Patients diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (collectively referred to as ovarian cancer) through open surgery, laparoscopic surgery, or core needle biopsy confirmed by pathology.
- Patients who will require neoadjuvant chemotherapy followed by direct surgery, or direct surgical chemotherapy.
- Liver Function:
Key exclusion criteria (14 listed)
- Are using other investigational drugs or participating in other clinical drug trials simultaneously;
- Have used or are currently using any medications that interact with statins;
- Have active cirrhosis, uncontrolled concurrent diseases, a history of chronic myopathy, active hepatitis, or unexplained persistent elevation of serum aminotransferases;
- Are known to be allergic to statins, or any active or inactive components of drugs with similar chemical structures;
- Are unable to swallow oral medications or have any gastrointestinal disorders that might interfere with the absorption and metabolism of the study drugs, such as uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption;
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 |
|---|---|---|
| StatinStatin Group: Conventional chemotherapy and maintenance therapy combined with statins. | Drug | Statin Group |
| Sugar pillControl Group: Conventional chemotherapy and maintenance therapy alone. | Drug | Control Group |
Primary outcome
Progression free survival
Time frame: 12-month
The time between the start of the trial and tumor progression (in any way) or death (from any cause)
Disease free survival
Time frame: 12-month
Time from surgical resection to local recurrence
3 secondary outcomes
Changes of tumor marker CA125
Time frame: 12-month
Changes of tumor marker HE4
Time frame: 12-month
Lipid change
Time frame: 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
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 and Sugar pill in people with Ovarian Cancer, run by Anhui Provincial Cancer 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 21 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bai-Rong Xia, Doctor (18604516165, xiabairong9999@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 12-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2024.