An interventional study of Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) in Endometrial Cancer, Endometrioid Carcinoma and Mismatch Repair Deficiency, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
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.
46 studies on the registry are indexed under Carcinoma, Endometrioid; 11 are open to participants now.
This study's planned enrollment of 10 is below the median of 79 across 36 interventional studies indexed under Carcinoma, Endometrioid.
Browse Carcinoma, Endometrioid studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
Compared within Carcinoma, Endometrioid, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Endometrial Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants
Drug: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)
1. Sintilimab or Pembrolizumab 200mg intravenous injection, every 3 weeks 2. MA, 320mg/MPA, 500mg, po, once a day
Also known as: Sintilimab or Pembrolizumab and MPA/MA
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
Complete remission (CR) rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor
Time frame: 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
Time frame: From start of treatment to trial completion, an average of 3 months
Recurrence rate
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences.
Time frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR
Pregnancy rate
A pregnancy test shows pregnancy after CR.
Time frame: 1 year after CR
Live birth rate
The live birth rate is defined as the ratio of live births to pregnancies.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jul 2029, 58 months after the start.
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Studies of the drug tested here: Pembrolizumab
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