Clinical trial NCT06417736: Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer Stage I
Endometrial Hyperplasia
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 24-week complete response(CR) rate
timeFrame: baseline,12 weeks after treatment,and 24 weeks of treatment
Secondary outcomes:
measure: 36-week CR rate
timeFrame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment
measure: 48-week CR rate
timeFrame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
measure: treatment-related adverse events
timeFrame: baseline,12 weeks after treatment,and 24 weeks of treatment
measure: recurrent rate
timeFrame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
measure: pregnancy rate
timeFrame: 1-year after CR
Other outcomes:
measure: CR in different molecular classification
timeFrame: baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Yang Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: