Intrauterine Injection of Type III Collage in FST of EC/AEH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Recombinant Humanized Type III Collagen Lyophilized Fibers + High-dose Progestin, High-dose Progestin.
- Who it may be relevant to
- Registry conditions: Atypical Endometrial Hyperplasia, Endometrial Cancer. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized, Open-Label, Controlled Clinical Trial of Intrauterine Injection of Recombinant Humanized Type III Collage in the Fertility-Sparing Treatment of Endometrial Cancer or Atypical Hyperplasia
Overview
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: 1. Does the combination of recombinant humanized type III collagen and progestin significantly increase the tumor remission rate at 6 months compared to progestin alone? 2. What medical problems do participants have when receiving this treatment (e.g., allergic reactions, abnormal inflammatory markers, or histocompatibility issues)? Researchers will compare "recombinant humanized type III collagen plus progestin (experimental group)" to "high-dose progestin alone (control group)" to see if the combination therapy is more effective for fertility preservation. Participants will: 1. Take high-dose progestin (such as Medroxyprogesterone Acetate or Megestrol Acetate) orally every day. 2. If assigned to the experimental group, receive one intrauterine submucosal injection of collagen via hysteroscopy at months 0, 1, and 2, for a total of 3 injections. 3. Visit the clinic once every 3 months for treatment evaluation and follow-up, which includes hysteroscopic endometrial biopsy, imaging (such as transvaginal ultrasound), and safety tests for relevant biochemical indicators.
Interventions
- Drug Recombinant Humanized Type III Collagen Lyophilized Fibers + High-dose Progestin
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 c - Drug High-dose Progestin
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
Primary outcome measures
- 6-month Tumor Complete Remission Rate [Time frame: 6 months after the start of treatment]
Secondary outcome measures (5)
- Time to Complete Response (CR) [Time frame: Up to 2 years]
- 1-Year Recurrence Rate [Time frame: 1 year after CR]
- Endometrial Thickness and Blood Flow [Time frame: Every 3 months during the 9-month treatment period]
- 1-Year Pregnancy Rate [Time frame: 1 year after treatment completion]
- Incidence of Adverse Events (Safety) [Time frame: Throughout the 9-month treatment period]
Eligibility criteria
Inclusion criteria
- Pathological diagnosis of endometrioid adenocarcinoma (G1 or G2) or atypical endometrial hyperplasia.
- For patients with endometrial cancer, magnetic resonance imaging (MRI) or ultrasound must confirm that the lesion is confined to the endometrium or invades less than 1/2 of the myometrium (i.e., FIGO 2009 Stage IA).
- Age ≤ 45 years.
- Desire to preserve fertility and signed informed consent.
- No serious medical comorbidities (e.g., severe liver or renal dysfunction).
- No contraindications to progestin therapy or pregnancy.
- No evidence of distant metastasis on imaging.
Exclusion criteria
- Tumor invasion > 1/2 of the myometrium, or FIGO (2009) Stage IB and above.
- Tumor differentiation grade G3 or non-endometrioid adenocarcinoma.
- Coexistence of other malignant tumors.
- Contraindications to conservative treatment or use of the study drugs.
- Known allergy to recombinant protein components.
- Acute genital tract inflammation or untreated abnormal vaginal discharge within 2 weeks prior to enrollment.
- Previous treatment with high-potency progestin for more than 1 month.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07377734 · 2024PHD014-001