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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 24-week complete response(CR) rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1.18-45 years old with a strong desire to preserve fertility;
- •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)
- •no signs of suspicious extrauterine metastasis by enhanced computed tomography and CT scan of the Lungs
排除标准
- •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
研究组 & 干预措施
membrane-inhibiting formula combined with oral progestins
Megestrol acetate(160mg/day) and membrane-inhibiting formula, 24weeks
干预措施: Megestrol Acetate 40 MG (Drug)
结局指标
主要结局
24-week complete response(CR) rate
时间窗: baseline,12 weeks after treatment,and 24 weeks of treatment
The treatment response:complete response,no endometrial lesion
次要结局
- 36-week CR rate(baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment)
- pregnancy rate(1-year after CR)
- recurrent rate(baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment)
- 48-week CR rate(baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment)
- treatment-related adverse events(baseline,12 weeks after treatment,and 24 weeks of treatment)