Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06468254

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

Led by Anhui Provincial Cancer Hospital · Updated on 2024-06-21

500

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 years and older
  • Diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed by pathology
  • Require neoadjuvant chemotherapy followed by surgery or direct surgical chemotherapy
  • Liver function with total bilirubin 641.5 times upper limit of normal (ULN) or direct bilirubin 641.0 times ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 642.5 times ULN; if liver metastases present, AST and ALT 645 times ULN
  • Kidney function with serum creatinine 641.5 times ULN or creatinine clearance rate 6560 mL/min
  • Able to understand and comply with trial procedures, treatments, tests, follow-ups, and questionnaires
Not Eligible

You will not qualify if you...

  • Using other investigational drugs or participating in other clinical drug trials
  • Using medications that interact with statins
  • Have active cirrhosis, uncontrolled diseases, chronic myopathy history, active hepatitis, or unexplained elevated serum aminotransferases
  • Allergic to statins or similar drug components
  • Unable to swallow oral medication or have gastrointestinal disorders affecting drug absorption or metabolism
  • Require treatment for symptomatic or uncontrolled brain metastases or have clinical signs of spinal cord compression
  • Have severe uncontrolled diseases such as active viral infections (HIV, hepatitis B or C), severe cardiovascular diseases, uncontrolled seizures, unstable spinal cord compression, superior vena cava syndrome, or psychiatric disorders affecting consent
  • Have uncontrolled hypertension not managed by medication or immune deficiencies
  • Medical history or conditions that may interfere with study adherence or safety
  • History or current evidence of other malignancies
  • Pregnant, breastfeeding, or planning pregnancy during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Anhui Cancer Hospital

Hefei, Anhui, China, 230001

Actively Recruiting

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Research Team

B

Bai-Rong Xia, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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