Intrauterine Injection of Type III Collage in FST of EC/AEH (2026ColECFerSp)

March 24, 2026 updated by: Wang Jianliu

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pathological diagnosis of endometrioid adenocarcinoma (G1 or G2) or atypical endometrial hyperplasia.
  2. 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).
  3. Age ≤ 45 years.
  4. Desire to preserve fertility and signed informed consent.
  5. No serious medical comorbidities (e.g., severe liver or renal dysfunction).
  6. No contraindications to progestin therapy or pregnancy.
  7. No evidence of distant metastasis on imaging.

Exclusion Criteria:

  1. Tumor invasion > 1/2 of the myometrium, or FIGO (2009) Stage IB and above.
  2. Tumor differentiation grade G3 or non-endometrioid adenocarcinoma.
  3. Coexistence of other malignant tumors.
  4. Contraindications to conservative treatment or use of the study drugs.
  5. Known allergy to recombinant protein components.
  6. Acute genital tract inflammation or untreated abnormal vaginal discharge within 2 weeks prior to enrollment.
  7. Previous treatment with high-potency progestin for more than 1 month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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
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 cavity, including the anterior, posterior, left, right, and fundal walls, or surrounding the suspected lesion area.
Active Comparator: Control Group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6-month Tumor Complete Remission Rate
Time Frame: 6 months after the start of treatment
6 months after the start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years
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.
1 year after CR
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.
Every 3 months during the 9-month treatment period
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.
1 year after treatment completion
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).
Throughout the 9-month treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wang Jianliu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PHD014-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

General clinical data and fertility-sparing treatment outcomes of patients in both the experimental and control groups will be shared.

IPD Sharing Time Frame

The data will be available within 6 months after the publication of the primary research paper.

IPD Sharing Access Criteria

Researchers interested in obtaining the clinical and treatment data can apply by contacting the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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