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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Women's Hospital School of Medicine Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Yang Li, Doctor
5516015@zju.edu.cn
0086-18268165386
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 75
Treatments
Experimental: membrane-inhibiting formula combined with oral progestins
Megestrol acetate(160mg/day) and membrane-inhibiting formula, 24weeks
Related Therapeutic Areas
Sponsors
Leads: Women's Hospital School Of Medicine Zhejiang University

This content was sourced from clinicaltrials.gov