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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAnhui Provincial Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Statin

    Drug

    Statin Group: Conventional chemotherapy and maintenance therapy combined with statins.

  • Sugar pill

    Drug

    Control Group: Conventional chemotherapy and maintenance therapy alone.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Statin GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

The time between the start of the trial and tumor progression (in any way) or death (from any cause)

Time frame
12-month
2

Disease free survival

Time from surgical resection to local recurrence

Time frame
12-month

Secondary outcomes

1

Changes of tumor marker CA125

Changes in Serum CA125 from Enrollment to End of Trial

Time frame
12-month
2

Changes of tumor marker HE4

Changes in Serum HE4 from Enrollment to End of Trial

Time frame
12-month
3

Lipid change

Changes in Serum Lipid from Enrollment to End of Trial

Time frame
12-month

Other outcomes

Sponsors and contacts

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