About this trial
To explore the treatment efficacy of Progesterone Therapeutic Regimen Plus Statins in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Atypical endometrial hyperplasia;
Patients with highly differentiated endometrioid adenocarcinoma, stage IA, and pelvic and abdominal MRI before treatment excluded deep muscle infiltration, cervical involvement, and extrauterine metastasis;
There is a strong need to preserve reproductive function; Age ≤45 years old;
Progesterone resistant patients predicted by the progesterone sensitivity prediction model (NCT05647109) established by our team in the previous study of endometrial cancer were prospectively randomized; The predicted progesterone sensitive patients were prospectively observed;
Disqualifiers
(1) Patients with severe internal diseases and severe impairment of liver and kidney function;
Trial design
Parallel
Treatments tested in this trial
statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);
DrugProgesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);
Treatment groups
Trial outcomes
Primary outcomes
Pathological cumulative complete response rate;
From 6 to 7 months: From date of initial therapy until the date of CR.
Secondary outcomes
Pathological cumulative complete response rate;
From 3 to 4 months; From date of initial therapy until the date of CR.
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion
Overall complete response rate
Pathological response duration
Relapse rate
Relapse rate
Sponsors and contacts
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Peking University People's Hospital
Lead sponsor
Beihang University
Collaborator
Peking University
Collaborator