Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women

Not Applicable

Recruiting

• Conditions: Endometrial Hyperplasia; Endometrial Cancer Stage I
• Interventions: Drug: Megestrol Acetate 40 MG

• Registration Number: NCT06417736
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-01
• Study First Submitted: 2024-05-12
• Study First Submitted QC: 2024-05-12
• Last Update Submitted: 2024-05-12
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
membrane-inhibiting formula combined with oral progestins	Megestrol Acetate 40 MG	Megestrol acetate(160mg/day) and membrane-inhibiting formula, 24weeks

Primary Outcome Measures

Name	Time	Method
24-week complete response(CR) rate	baseline,12 weeks after treatment,and 24 weeks of treatment	The treatment response:complete response,no endometrial lesion

Secondary Outcome Measures

Name	Time	Method
36-week CR rate	baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment	The treatment response:complete response,no endometrial lesion
pregnancy rate	1-year after CR	long term fertility results
recurrent rate	baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment	cumulative recurrent rate
48-week CR rate	baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment	The treatment response:complete response,no endometrial lesion
treatment-related adverse events	baseline,12 weeks after treatment,and 24 weeks of treatment	analyze the safety of the drug

Trial Locations

Locations (1)

Women's Hospital School of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China