NCT06549855

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
42mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Oct 2024Oct 2029

First Submitted

Initial submission to the registry

July 21, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

4.8 years

First QC Date

July 21, 2024

Last Update Submit

August 8, 2024

Conditions

Endometrial CancerEndometrioid CarcinomaMismatch Repair Deficiency

Keywords

Fertility preservationEndometrioid CarcinomaPD-1 inhibitor

Outcome Measures

Primary Outcomes (2)

  • Complete remission (CR) rate

    No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor

    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

    From start of treatment to trial completion, an average of 3 months

Secondary Outcomes (6)

  • Recurrence rate

    6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR

  • Pregnancy rate

    1 year after CR

  • Live birth rate

    1 year after pregnancy

  • Pathological biomarker

    From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth.

  • CA125

    From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.

  • +1 more secondary outcomes

Study Arms (1)

PD-1 Inhibitor Combined With Progesterone Treatment

EXPERIMENTAL

All participants

Drug: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)

Interventions

Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)DRUG

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
PD-1 Inhibitor Combined With Progesterone Treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Endometrial NeoplasmsCarcinoma, EndometrioidTurcot syndrome

Interventions

sintilimabpembrolizumabMedroxyprogesterone AcetateMegestrol Acetate

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMegestrolPregnadienes

Study Officials

  • Jianliu Wang, Professor

    Peking University People's Hospital

    STUDY CHAIR

Central Study Contacts

Jianliu Wang, Professor

CONTACT

0086-010-88324381wangjianliu1203@163.com

Yiqin Wang

CONTACT

emily_wang92@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-president of Peking University People's Hospital

Study Record Dates

First Submitted

July 21, 2024

First Posted

August 12, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)