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

NCT07377734 | Recruiting Phase 2 DMC

• 1 other identifier: 2024PHD014-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.
3. 3.Take high-dose progestin (such as Medroxyprogesterone Acetate or Megestrol Acetate) orally every day.
4. 4.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.
5. 5.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.

Conditions

Atypical Endometrial Hyperplasia; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 6-month Tumor Complete Remission Rate

  6 months after the start of treatment

Secondary Outcomes (5)

• Time to Complete Response (CR)

  Up to 2 years

• 1-Year Recurrence Rate

  1 year after CR

• Endometrial Thickness and Blood Flow

  Every 3 months during the 9-month treatment period

• 1-Year Pregnancy Rate

  1 year after treatment completion

• Incidence of Adverse Events (Safety)

  Throughout the 9-month treatment period

Study Arms (2)

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

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

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

Drug: High-dose Progestin

Interventions

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

Control Group

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wang Jianliu: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Interventions

Progestins

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Yiqin Wang

CONTACT

+86-15201277651; emily_wang92@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available within 6 months after the publication of the primary research paper.
• Access Criteria: Researchers interested in obtaining the clinical and treatment data can apply by contacting the principal investigator.

Locations

CN (1)