PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer

August 8, 2024 updated by: Wang Jianliu, Peking University People's Hospital

PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Peking University People's Hospital
        • Contact:
          • Jianliu Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-1 Inhibitor Combined With Progesterone Treatment
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
Other Names:
  • Sintilimab or Pembrolizumab and MPA/MA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission (CR) rate
Time Frame: 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
From start of treatment to trial completion, an average of 3 months
Time to CR
Time Frame: 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
From start of treatment to trial completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences.
6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR
Pregnancy rate
Time Frame: 1 year after CR
A pregnancy test shows pregnancy after CR.
1 year after CR
Live birth rate
Time Frame: 1 year after pregnancy
The live birth rate is defined as the ratio of live births to pregnancies.
1 year after pregnancy
Pathological biomarker
Time Frame: From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth.
pathological markers(such as Ki-67, estrogen receptor, progesterone receptor, p53, PTEN, MLH1, PMS2, MSH2, and MSH6) at each hysteroscopy
From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth.
CA125
Time Frame: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
Used as a tumor marker for disease monitoring
From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
Adverse reactions
Time Frame: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
Any unfavorable response resulting from the administration of any pharmaceutical agent utilized as part of the therapeutic regimen.
From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Shandong University
Peking Union Medical College Hospital
Peking University Third Hospital
Shengjing Hospital
Huazhong University of Science and Technology
Beijing Chao Yang Hospital
Tianjin Medical University

Investigators

  • Study Chair: Jianliu Wang, Professor, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024MMRdECFerSp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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