NCT07377734RecruitingPhase 2
Intrauterine Injection of Type III Collage in FST of EC/AEH
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
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Jan 2026
- Start date
- 30 Jan 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Wang Jianliu
- Diseases
- Endometrial cancer
- NCT number
- NCT07377734
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 30 Jan 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to conservative treatment or use of the study drugs.
- 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.
Other illness
- Coexistence of other malignant tumors.
- Known allergy to recombinant protein components.
Other
- Tumor invasion \> 1/2 of the myometrium, or FIGO (2009) Stage IB and above.
- Tumor differentiation grade G3 or non-endometrioid adenocarcinoma.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.