About this trial
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 criteria
Qualifiers
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);
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)
Treatment groups
Sponsors and collaborators
Peking University People's Hospital
Lead sponsor
Peking Union Medical College Hospital
Collaborator
Peking University Third Hospital
Collaborator
Huazhong University of Science and Technology
Collaborator
Tianjin Medical University
Collaborator
Shandong University
Collaborator
Shengjing Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator