Atypical Endometrial HyperplasiaPhase 22026ColECFerSpNCT07377734
Intrauterine Injection of Type III Collage in FST of EC/AEH
A Phase 2 study testing Recombinant Humanized Type III Collagen Lyophilized Fibers + High-dose Progestin and High-dose Progestin in people with Atypical Endometrial Hyperplasia and Endometrial Cancer, run by Wang Jianliu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Atypical Endometrial Hyperplasia, Endometrial Cancer
- What is being tested?
- Recombinant Humanized Type III Collagen Lyophilized Fibers + High-dose Progestin and High-dose Progestin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2026to 30 Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Yiqin Wang, +86-15201277651, emily_wang92@163.com
About this study
Official title: 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
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:
- Does the combination of recombinant humanized type III collagen and progestin significantly increase the tumor remission rate at 6 months compared to progestin alone?
- 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.
Read more
Participants will:
- Take high-dose progestin (such as Medroxyprogesterone Acetate or Megestrol Acetate) orally every day.
- 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.
- 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.
- Being tested
- Recombinant Humanized Type III Collagen Lyophilized Fibers + High-dose Progestin, High-dose Progestin
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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 Receives: Drug: Recombinant Humanized Type III Collagen Lyophilized Fibers + High-dose Progestin |
| Control Group | Active comparator | 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 Receives: Drug: High-dose Progestin |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Tumor Complete Remission Rate
Measured: 6 months after the start of treatment
Secondary outcomes (5)
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.
Measured: 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.
Measured: 1 year after CR
Endometrial Thickness and Blood Flow
Evaluation of endometrial thickness (mm) and blood flow status (via Doppler) assessed by transvaginal ultrasound.
Measured: 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.
Measured: 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).
Measured: Throughout the 9-month treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start30 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Endometrial HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Jianliu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Jianliu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377734
- Sponsor's protocol ID
- 2024PHD014-001
- Acronym
- 2026ColECFerSp
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: General clinical data and fertility-sparing treatment outcomes of patients in both the experimental and control groups will be shared.