NCT07377734 Intrauterine Injection of Type III Collage in FST of EC/AEH
| NCT ID | NCT07377734 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Wang Jianliu |
| Condition | Atypical Endometrial Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2026-01-30 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07377734 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Atypical Endometrial Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07377734 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07377734 currently recruiting?
Yes, NCT07377734 is actively recruiting participants. Contact the research team at emily_wang92@163.com for enrollment information.
Where is the NCT07377734 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07377734 clinical trial?
NCT07377734 is sponsored by Wang Jianliu. The trial plans to enroll 30 participants.