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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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 c
• Препарат 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

Первичные конечные точки

• 6-month Tumor Complete Remission Rate [Срок оценки: 6 months after the start of treatment]

Вторичные конечные точки (5)

• Time to Complete Response (CR) [Срок оценки: Up to 2 years]
• 1-Year Recurrence Rate [Срок оценки: 1 year after CR]
• Endometrial Thickness and Blood Flow [Срок оценки: Every 3 months during the 9-month treatment period]
• 1-Year Pregnancy Rate [Срок оценки: 1 year after treatment completion]
• Incidence of Adverse Events (Safety) [Срок оценки: Throughout the 9-month treatment period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07377734 · 2024PHD014-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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