PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPeking University People's Hospital
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)
Drug1. Sintilimab or Pembrolizumab 200mg intravenous injection, every 3 weeks 2. MA, 320mg/MPA, 500mg, po, once a day
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: PD-1 Inhibitor Combined With Progesterone TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 CR2
Pregnancy rate
A pregnancy test shows pregnancy after CR.
Time frame
1 year after CR3
Live birth rate
The live birth rate is defined as the ratio of live births to pregnancies.
Time frame
1 year after pregnancy4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov