Prospective Clinical Study of Fertility-sparing Treatment With a Membrane-inhibiting Formula Combined With Oral Progestins for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women
Overview
- Phase
- N/A
- Intervention
- Megestrol Acetate 40 MG
- Conditions
- Endometrial Cancer Stage I
- Sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- 24-week complete response(CR) rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •1.18-45 years old with a strong desire to preserve fertility;
- •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)
- •no signs of suspicious extrauterine metastasis by enhanced computed tomography and CT scan of the Lungs
Exclusion Criteria
- •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
Arms & Interventions
membrane-inhibiting formula combined with oral progestins
Megestrol acetate(160mg/day) and membrane-inhibiting formula, 24weeks
Intervention: Megestrol Acetate 40 MG
Outcomes
Primary Outcomes
24-week complete response(CR) rate
Time Frame: baseline,12 weeks after treatment,and 24 weeks of treatment
The treatment response:complete response,no endometrial lesion
Secondary Outcomes
- 36-week CR rate(baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment)
- pregnancy rate(1-year after CR)
- recurrent rate(baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment)
- 48-week CR rate(baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment)
- treatment-related adverse events(baseline,12 weeks after treatment,and 24 weeks of treatment)