Endometrial CancerNCT06549855
PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer
A study testing Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) in people with Endometrial Cancer and Endometrioid Carcinoma, run by Peking University People's Hospital at 1 site in China.
Trial summary
The objective of this study was to investigate the feasibility of a PD-1 inhibitor in combination with progesterone as a means of preserving fertility in patients with early-stage mismatch repair-deficient (MMRd) endometrial cancer who wish to preserve fertility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial Cancer, Endometrioid Carcinoma, Mismatch Repair Deficiency
- What is being tested?
- Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2024to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yiqin Wang contact
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jianliu Wang, +8688324380, wangjianliu1203@163.com
About this study
Official title: PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer
The objective of this study was to investigate the feasibility of a PD-1 inhibitor in combination with progesterone as a means of preserving fertility in patients with early-stage mismatch repair-deficient (MMRd) endometrial cancer who wish to preserve fertility.
Read the detailed description
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence. The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy. However, given the rising incidence of endometrial cancer in younger individuals and the the delay in the age of human reproduction, the conservation of endometrial cancer has garnered heightened attention. Clinical practice has demonstrated that high-dose progesterone can reverse the lesioned endometrium, thereby providing a rationale for the conservative treatment of early-stage endometrial cancer.
PD-1 inhibitor has been utilized as a salvage treatment in many cancers including ovarian cancer, cervical cancer, lung cancer, gastric cancer and endometrial cancer. As endometrial cancer showed MMRd rates, it is assumed to be highly responsive to PD-1 inhibitor treatment. Previous literature has reported that the efficacy of progesterone therapy is limited in patients with a MMRd status.Here we want to investigate the feasibility of PD-1 inhibitor combined with progesterone in early stage endometrial cancer patients who want to preserve fertility.
- Being tested
- Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)
- Keywords
- Fertility preservation, Endometrioid Carcinoma, PD-1 inhibitor
- Medical subject headings
- Endometrial Neoplasms, Carcinoma, Endometrioid, Turcot syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)Drug
Also called Sintilimab or Pembrolizumab and MPA/MA
- Sintilimab or Pembrolizumab 200mg intravenous injection, every 3 weeks
- MA, 320mg/MPA, 500mg, po, once a day
| Study group | Role | What they receive |
|---|---|---|
| PD-1 Inhibitor Combined With Progesterone Treatment | Experimental | All participants Receives: Drug: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor
Measured: From start of treatment to trial completion, an average of 3 months
Time to CR
Time to CR was calculated from the commencement of fertility-preserving treatment to the date of the initial hysteroscopic examination to confirm CR
Measured: From start of treatment to trial completion, an average of 3 months
Secondary outcomes (6)
Recurrence rate
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences.
Measured: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR
Pregnancy rate
A pregnancy test shows pregnancy after CR.
Measured: 1 year after CR
Live birth rate
The live birth rate is defined as the ratio of live births to pregnancies.
Measured: 1 year after pregnancy
Pathological biomarker
pathological markers(such as Ki-67, estrogen receptor, progesterone receptor, p53, PTEN, MLH1, PMS2, MSH2, and MSH6) at each hysteroscopy
Measured: From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth.
CA125
Used as a tumor marker for disease monitoring
Measured: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
Adverse reactions
Any unfavorable response resulting from the administration of any pharmaceutical agent utilized as part of the therapeutic regimen.
Measured: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start2 Sep 2024
- Primary completionJul 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University Third Hospital, Huazhong University of Science and Technology, Tianjin Medical University, Shandong University, Shengjing Hospital, Beijing Chao Yang Hospital
- Responsible party
- Principal investigator, Wang Jianliu, Peking University People's Hospital
- Investigators
- Jianliu Wang, Professor, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549855
- Sponsor's protocol ID
- 2024MMRdECFerSp
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06549855
- Acronym / sponsor ID
- 2024MMRdECFerSp
- Keywords
- Fertility preservation, Endometrioid Carcinoma, PD-1 inhibitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University Third Hospital, Huazhong University of Science and Technology, Tianjin Medical University, Shandong University, Shengjing Hospital, Beijing Chao Yang Hospital
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to investigate the feasibility of a PD-1 inhibitor in combination with progesterone as a means of preserving fertility in patients with early-stage mismatch repair-deficient (MMRd) endometrial cancer who wish to preserve fertility.
Detailed description
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence. The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy. However, given the rising incidence of endometrial cancer in younger individuals and the the delay in the age of human reproduction, the conservation of endometrial cancer has garnered heightened attention. Clinical practice has demonstrated that high-dose progesterone can reverse the lesioned endometrium, thereby providing a rationale for the conservative treatment of early-stage endometrial cancer.
PD-1 inhibitor has been utilized as a salvage treatment in many cancers including ovarian cancer, cervical cancer, lung cancer, gastric cancer and endometrial cancer. As endometrial cancer showed MMRd rates, it is assumed to be highly responsive to PD-1 inhibitor treatment. Previous literature has reported that the efficacy of progesterone therapy is limited in patients with a MMRd status.Here we want to investigate the feasibility of PD-1 inhibitor combined with progesterone in early stage endometrial cancer patients who want to preserve fertility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 Inhibitor Combined With Progesterone Treatment | Experimental | Drug: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)All participants |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)Also: Sintilimab or Pembrolizumab and MPA/MA1. Sintilimab or Pembrolizumab 200mg intravenous injection, every 3 weeks 2. MA, 320mg/MPA, 500mg, po, once a day | Drug | PD-1 Inhibitor Combined With Progesterone Treatment |
Primary outcome
Complete remission (CR) rate
Time frame: From start of treatment to trial completion, an average of 3 months
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor
Time to CR
Time frame: From start of treatment to trial completion, an average of 3 months
Time to CR was calculated from the commencement of fertility-preserving treatment to the date of the initial hysteroscopic examination to confirm CR
6 secondary outcomes
Recurrence rate
Time frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR
Pregnancy rate
Time frame: 1 year after CR
Live birth rate
Time frame: 1 year after pregnancy
Pathological biomarker
Time frame: From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth.
CA125
Time frame: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
Adverse reactions
Time frame: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yiqin Wang contact
Jianliu Wang, Professor study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) in people with Endometrial Cancer and Endometrioid Carcinoma, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianliu Wang, Professor (0086-010-88324381, wangjianliu1203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (CR) rate (time frame: From start of treatment to trial completion, an average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.