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

Wang Jianliu

Status and phase: Not yet enrolling; Phase 2

Conditions: Endometrial Cancer; Atypical Endometrial Hyperplasia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07377734

2024PHD014-001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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

Treatment:

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

Control Group

Active Comparator group

Description:

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

Treatment:

Drug: High-dose Progestin