Intrauterine Injection of Type III Collage in FST of EC/AEH

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorWang Jianliu

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Recombinant Humanized Type III Collagen Lyophilized Fibers + High-dose Progestin
  • High-dose Progestin

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Wang Jianliu

Lead sponsor

Peking University People's Hospital

Sponsor institution