About this trial
The goal of this clinical trial is to evaluate the effect and adverse side effects of membrane-inhibiting formula plus oral progestins as fertility-preserving treatment in patients with early-stage endometrial cancer and endometrial hyperplasia research questions:When taken with oral progestins, does the drug membrane-inhibiting formula shorten the time required for complete endometrial remission? What medical problems do participants have when taking drug membrane-inhibiting formula plus oral progestins? Efficacy, side effects, recurrence, pregnancy, and time to obtain pregnancy in different molecular classifications of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt), and p53-abnormal(p53abn).
Participants will: Take drug membrane-inhibiting formula plus oral progestins every day Visit the clinic once every 3 months for checkups, tests, and hysteroscopy Keep a diary of examination results and pathology
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1.18-45 years old with a strong desire to preserve fertility; 2. pathologically diagnosed with primary grade1 or grade2 endometrioid endometrial carcinoma and hyperplasia 3.no signs of suspicious myometrial invasion by enhanced magnetic resonance imaging (MRI) 4. no signs of suspicious extrauterine metastasis by enhanced computed tomography and CT scan of the Lungs
Disqualifiers
1.have contraindication for pregnancy. 2.no fertility requiremen 3.have myometrial invasion or extrauterine metastasis 4.pathologically diagnosed with primary grade3 endometrioid endometrial carcinoma or non-endometrioid endometrial carcinoma 5.Any disease or symptom that may affect the implementation of the study or the interpretation of the results
Trial design
Single group
Treatments tested in this trial
Megestrol Acetate 40 MG
Drug160mg/one time/day
Treatment groups
Trial outcomes
Primary outcomes
24-week complete response(CR) rate
The treatment response:complete response,no endometrial lesion
Secondary outcomes
36-week CR rate
The treatment response:complete response,no endometrial lesion
48-week CR rate
The treatment response:complete response,no endometrial lesion
treatment-related adverse events
analyze the safety of the drug
recurrent rate
cumulative recurrent rate
Other outcomes
CR in different molecular classification
Efficacy in different molecular classification of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt),and p53-abnormal(p53abn)
Sponsors and contacts
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