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

Women's Hospital School Of Medicine Zhejiang University75 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometrial Cancer Stage I Endometrial Hyperplasia

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

24-week complete response(CR) rate

The treatment response:complete response,no endometrial lesion

Time frame: baseline,12 weeks after treatment,and 24 weeks of treatment

Secondary Outcomes

36-week CR rate

The treatment response:complete response,no endometrial lesion

Time frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment

48-week CR rate

The treatment response:complete response,no endometrial lesion

Time frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

treatment-related adverse events

analyze the safety of the drug

Time frame: baseline,12 weeks after treatment,and 24 weeks of treatment

recurrent rate

cumulative recurrent rate

Time frame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment

pregnancy rate

long term fertility results

Time frame: 1-year after CR

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts