Intrauterine type III collagen injection plus progestin for fertility-preserving endometrial cancer or atypical hyperplasia

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

This test sees if adding an intrauterine injection of recombinant humanized type III collagen to high‑dose progestin helps women with early endometrial cancer or atypical hyperplasia preserve fertility and achieve tumor remission.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Peking University People's Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07377734 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study compares intrauterine recombinant humanized type III collagen plus high‑dose progestin versus high‑dose progestin alone in women seeking fertility preservation. Eligible participants are age 45 or younger with endometrioid G1–G2 cancer confined to the endometrium or invading less than half the myometrium (FIGO IA) or with atypical endometrial hyperplasia. The primary efficacy outcome is tumor remission at 6 months, and safety monitoring will track allergic reactions, abnormal inflammatory markers, and other adverse events related to the recombinant protein and progestin. Imaging and pathology are used for baseline staging and to determine response, with regular clinical follow‑up to record reproductive outcomes and complications.

Who should consider this trial

Good fit: Women ≤45 years with endometrioid G1–G2 endometrial cancer confined to the endometrium or invading <1/2 myometrium (FIGO IA), or with atypical endometrial hyperplasia, who wish to preserve fertility and have no major comorbidities are ideal candidates.

Not a fit: Patients with tumor invasion ≥1/2 myometrium (FIGO IB or higher), grade 3 or non‑endometrioid histology, concurrent other malignancies, known allergy to recombinant proteins, or contraindications to conservative/progestin therapy are unlikely to benefit.

Why it matters

Potential benefit: If successful, the combination could increase 6‑month remission rates and allow more women to avoid hysterectomy and retain fertility.

How similar studies have performed: High‑dose progestin alone has shown remission in many fertility‑sparing cases, but using intrauterine recombinant type III collagen as an adjunct is novel and has limited prior human data.

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.

Where this trial is running

Beijing

• Peking University People's Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yiqin Wang

Conditions Atypical Endometrial Hyperplasia; Endometrial Cancer