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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Megestrol Acetate 40 MG

    Drug

    160mg/one time/day

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: membrane-inhibiting formula combined with oral progestinsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

treatment-related adverse events

analyze the safety of the drug

Time frame
baseline,12 weeks after treatment,and 24 weeks of treatment
4

recurrent rate

cumulative recurrent rate

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

Other outcomes

1

CR in different molecular classification

Efficacy in different molecular classification of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt),and p53-abnormal(p53abn)

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.