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

Phase 2Not Yet RecruitingNCT07377734

Wang Jianliu30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atypical Endometrial Hyperplasia

Interventions

Recombinant Humanized Type III Collagen Lyophilized Fibers + High-dose ProgestinDRUG

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 ProgestinDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

6-month Tumor Complete Remission Rate

Time frame: 6 months after the start of treatment

Secondary Outcomes

Time to Complete Response (CR)

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

Time frame: Up to 2 years

1-Year Recurrence Rate

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.

Time frame: 1 year after CR

Endometrial Thickness and Blood Flow

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

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

1-Year Pregnancy Rate

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

Time frame: 1 year after treatment completion

Incidence of Adverse Events (Safety)

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).

Time frame: Throughout the 9-month treatment period