Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| membrane-inhibiting formula combined with oral progestins | Experimental | Megestrol acetate(160mg/day) and membrane-inhibiting formula, 24weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Megestrol Acetate 40 MG | Drug | 160mg/one time/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-week complete response(CR) rate | The treatment response:complete response,no endometrial lesion | baseline,12 weeks after treatment,and 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 36-week CR rate | The treatment response:complete response,no endometrial lesion | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment |
Inclusion Criteria:
Exclusion Criteria:
female
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Li, Doctor | Contact | 0086-18268165386 | 5516015@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yang Li, Doctor | Women's Hospital School Of Medicine Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital School of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 321006 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D004714 | Endometrial Hyperplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | baseline,12 weeks after treatment,and 24 weeks of treatment |
| recurrent rate | cumulative recurrent rate | baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment |
| pregnancy rate | long term fertility results | 1-year after CR |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |