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Can immunotherapy plus hormones spare the womb in early endometrial cancer?

NCT ID NCT06549855

Disease control Sponsor: Peking University People's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial is investigating whether combining an immunotherapy drug (a PD-1 inhibitor like sintilimab or pembrolizumab) with progesterone therapy can help young women with early-stage, mismatch repair-deficient (MMRd) endometrial cancer achieve complete remission while preserving their fertility. The study enrolls women aged 18-45 with stage IA, grade 1-2 endometrioid adenocarcinoma who strongly desire to avoid hysterectomy. Participants receive the PD-1 inhibitor intravenously every three weeks along with daily oral progesterone, and researchers will measure how many achieve complete remission, how long it takes, and subsequent pregnancy and live birth rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sintilimab or Pembrolizumab combined with medroxyprogesterone acetate (MPA) or megestrol acetate (MA)
What this could lead to
If successful, this combination could offer a fertility-sparing treatment option for young women with early-stage MMRd endometrial cancer, potentially allowing them to achieve remission without hysterectomy and preserve their ability to have children.
What could go wrong
This is a very small early-stage trial (10 participants), so results may not be generalizable. The combination may not improve remission rates, and there are risks of side effects from immunotherapy and hormonal therapy, including immune-related adverse events.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Carcinoma, Endometrioid endometrial cancer endometrioid adenocarcinoma endometrium neoplasm mismatch repair cancer syndrome 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial cancer Endometrioid carcinoma Mismatch repair deficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

More trials for these conditions

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