Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)
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
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Complete remission (CR) rate — 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 — 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
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
Beijing Municipality
Recruiting
More Peking University People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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