An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer: a Prospective, Multicenter Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06468254
• Other study ID #: 2024 NO. 049
• Status: Recruiting
• Phase: Phase 2
• Start date: June 30, 2024
• Est. completion date: March 30, 2026

Study information

• Verified date: June 2024
• Source: Anhui Provincial Cancer Hospital
• Contact: Bai-Rong Xia, Doctor
• Phone: 18604516165
• Email: xiabairong9999[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. Total bilirubin =1.5 times the upper limit of normal (ULN) or direct bilirubin =1.0 times ULN;

2. 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.

Exclusion Criteria:

• 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;

• 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:

1. Active viral infections such as HIV, hepatitis B, or hepatitis C.

2. Severe cardiovascular diseases, including uncontrolled ventricular arrhythmias or a recent (within the last 3 months) myocardial infarction.

3. Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorders affecting the ability to provide informed consent.

4. 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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Statin
Statin Group: Conventional chemotherapy and maintenance therapy combined with statins.
• Sugar pill
Control Group: Conventional chemotherapy and maintenance therapy alone.

Locations

Country	Name	City	State
China	Anhui Cancer Hospital	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	The time between the start of the trial and tumor progression (in any way) or death (from any cause)	12-month
Primary	Disease free survival	Time from surgical resection to local recurrence	12-month
Secondary	Changes of tumor marker CA125	Changes in Serum CA125 from Enrollment to End of Trial	12-month
Secondary	Changes of tumor marker HE4	Changes in Serum HE4 from Enrollment to End of Trial	12-month
Secondary	Lipid change	Changes in Serum Lipid from Enrollment to End of Trial	12-month