Endometrial Cancer Stage I, Endometrial Hyperplasia
Conditions
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
Interventions
160mg/one time/day
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-week complete response(CR) rate | baseline,12 weeks after treatment,and 24 weeks of treatment | The treatment response:complete response,no endometrial lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 36-week CR rate | baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment | The treatment response:complete response,no endometrial lesion |
| 48-week CR rate | baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment | The treatment response:complete response,no endometrial lesion |
| recurrent rate | baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment | cumulative recurrent rate |
| pregnancy rate | 1-year after CR | long term fertility results |
| treatment-related adverse events | baseline,12 weeks after treatment,and 24 weeks of treatment | analyze the safety of the drug |
Other
| Measure | Time frame | Description |
|---|---|---|
| CR in different molecular classification | baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment | Efficacy in different molecular classification of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt),and p53-abnormal(p53abn) |
Countries
China
Contacts
Primary ContactYang Li, Doctor
Outcome results
None listed