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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yiqin Wang
• Email: emily_wang92@163.com
• Phone: +86-15201277651

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.