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The goal of this clinical trial is to learn if intrauterine injection of "Recombinant Humanized Type III Collagen Lyophilized Fibers" works to treat endometrial cancer or atypical hyperplasia in patients seeking fertility-preserving treatment. It will also learn about the safety of this intervention.The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Participants in this arm will receive a combination therapy of oral high-dose progestin and intrauterine injections of Recombinant Humanized Type III Collagen Lyophilized Fibers for fertility preservation |
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| Control Group | Active Comparator | Participants in this arm receive the current standard-of-care treatment for fertility preservation in endometrial cancer, which consists of oral high-dose progestin alone. This allows for a direct comparison of efficacy and safety between the progestin-only therapy and the progestin-collagen combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Humanized Type III Collagen Lyophilized Fibers + High-dose Progestin | Drug | Participants in this group will receive a combination therapy. They will take oral high-dose progestin (Medroxyprogesterone Acetate 250mg-500mg/d or Megestrol Acetate 160mg-320mg/d) daily. Additionally, they will receive three intrauterine submucosal injections of Recombinant Humanized Type III Collagen Lyophilized Fibers (50mg per injection) via hysteroscopy at months 0, 1, and 2. Each injection consists of 5ml solution (10mg/ml). The injection is administered at specific sites in the uterine cavity, including the anterior, posterior, left, right, and fundal walls, or surrounding the suspected lesion area. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Tumor Complete Remission Rate | 6 months after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Response (CR) | The duration from the start of treatment to the first documentation of Complete Response (CR), based on negative pathological biopsy and clear imaging findings. | Up to 2 years |
| 1-Year Recurrence Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiqin Wang | Contact | +86-15201277651 | emily_wang92@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | China |
General clinical data and fertility-sparing treatment outcomes of patients in both the experimental and control groups will be shared.
The data will be available within 6 months after the publication of the primary research paper.
Researchers interested in obtaining the clinical and treatment data can apply by contacting the principal investigator.
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| ID | Term |
|---|---|
| D004714 | Endometrial Hyperplasia |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D011372 | Progestins |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| High-dose Progestin | Drug | Participants in the control group will receive standard-of-care treatment with oral high-dose progestin alone. The dosage will be Medroxyprogesterone Acetate 250mg-500mg/day or Megestrol Acetate 160mg-320mg/day, taken daily throughout the treatment period |
|
The proportion of participants who experience disease recurrence within 12 months after achieving Complete Response. Recurrence is defined as reappearance of cancer evidence in pathology or imaging.
| 1 year after CR |
| Endometrial Thickness and Blood Flow | Evaluation of endometrial thickness (mm) and blood flow status (via Doppler) assessed by transvaginal ultrasound. | Every 3 months during the 9-month treatment period |
| 1-Year Pregnancy Rate | The percentage of participants who achieve clinical pregnancy within one year following the end of treatment. | 1 year after treatment completion |
| Incidence of Adverse Events (Safety) | Monitoring for adverse events, including allergic reactions (rash, itching), systemic inflammatory markers (Complete Blood Count, C-Reactive Protein), and organ function (liver and kidney function tests). | Throughout the 9-month treatment period |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D020164 | Chemical Actions and Uses |