PD-1 inhibitor with progesterone to preserve fertility in early‑stage MMRd endometrial cancer
Official title: PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer
Run by Peking University People's Hospital · NCT06549855 · Data updated 2026-11-12
This study tests whether giving a PD-1 inhibitor together with progesterone can help young patients with early, MMRd endometrial cancer preserve fertility.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 2, 2024 |
| Main results expected | July 2029 |
| Study ends | October 2029 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT06549855 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–45 with stage IA, G1–G2 endometrioid endometrial cancer and confirmed MMR deficiency who strongly desire fertility preservation.
✕Probably not a fit
Patients with tumors beyond stage IA, non-endometrioid histology, or contraindications to PCM/MA or immunotherapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study explores the feasibility of combining a PD-1 inhibitor (Sintilimab or Pembrolizumab) with progestin therapy (medroxyprogesterone acetate or megestrol acetate) in women with early-stage, MMR-deficient endometrioid endometrial cancer who wish to preserve fertility. Eligible participants are aged 18–45 with FIGO stage IA disease and confirmed MMR deficiency, planning fertility preservation. The trial assesses whether this combination can control the cancer while avoiding hysterectomy, relying on local pathology and molecular testing to select patients and monitor response. Endometrial cancer is commonly treated with hysterectomy, but this approach seeks a conservative option for properly selected patients. Safety and feasibility outcomes will guide future work in fertility-sparing management.
Why it matters
Potential benefit: If successful, participants may maintain fertility while achieving disease control without uterus-removing surgery.
How similar studies have gone: PD-1 inhibitors have shown activity in endometrial cancer, but data on combining with progestin for fertility preservation are limited/experimental.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be between the ages of 18-45 years old; * Stage IA (FIGO 2009) ; * Confirmed diagnosis of endometrial adenocarcinoma G1-G2 based upon D\&C or hysteroscopy; * Molecular classification of MMRd, determined by immunohistochemical (IHC) for MMR proteins and by the second generation sequencing (NGS) or microsatellite polymerase chain reaction (PCR); * With a strong desire for fertility preservation; * Sign the informed consent. Exclusion Criteria: * Stage IB(FIGO 2009) and above; * Tumour differentiation of G3 or non-endometrioid adenocarcinoma; * Complicated with any other malignancy; * Contraindicated to conservative treatment or the use of pharmaceuticals. * Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.
Where it's running
-
Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Jianliu Wang, Professor
- Email: wangjianliu1203@163.com
- Phone: 0086-010-88324381
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.