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NCT Number: NCT07377734

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

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.

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Key information

Conditions

Atypical Endometrial Hyperplasia Endometrial Cancer Endometrial Hyperplasia Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. 6-month Tumor Complete Remission Rate

    Time frame: 6 months after the start of treatment

Secondary outcomes

  1. Time to Complete Response (CR)

    Time frame: Up to 2 years

    The duration from the start of treatment to the first documentation of Complete Response (CR), based on negative pathological biopsy and clear imaging findings.

  2. 1-Year Recurrence Rate

    Time frame: 1 year after CR

    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.

  3. Endometrial Thickness and Blood Flow

    Time frame: Every 3 months during the 9-month treatment period

    Evaluation of endometrial thickness (mm) and blood flow status (via Doppler) assessed by transvaginal ultrasound.

  4. 1-Year Pregnancy Rate

    Time frame: 1 year after treatment completion

    The percentage of participants who achieve clinical pregnancy within one year following the end of treatment.

  5. Incidence of Adverse Events (Safety)

    Time frame: Throughout the 9-month treatment period

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Yiqin Wang

CONTACT

[email protected]

+86-15201277651

Sponsors and collaborators

Lead sponsor

Wang Jianliu

Other

Registry information

Official study 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

Acronym: 2026ColECFerSp

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jan 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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