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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Endometrial Cancer Stage I Endometrial Hyperplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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membrane-inhibiting formula combined with oral progestins

Megestrol acetate(160mg/day) and membrane-inhibiting formula, 24weeks

Group Type EXPERIMENTAL

Megestrol Acetate 40 MG

Intervention Type DRUG

160mg/one time/day

Interventions

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Megestrol Acetate 40 MG

160mg/one time/day

Intervention Type DRUG

Other Intervention Names

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membrane-inhibiting formula

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No