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NCT Number: NCT06549855

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug
  • Sintilimab or Pembrolizumab 200mg intravenous injection, every 3 weeks
  • MA, 320mg/MPA, 500mg, po, once a day

Other names: Sintilimab or Pembrolizumab and MPA/MA

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. Pregnancy rate

    Time frame: 1 year after CR

    A pregnancy test shows pregnancy after CR.

  3. Live birth rate

    Time frame: 1 year after pregnancy

    The live birth rate is defined as the ratio of live births to pregnancies.

  4. 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

  5. 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

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianliu Wang, Professor

CONTACT

[email protected]

0086-010-88324381

Yiqin Wang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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