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Not yet recruiting NCT06549855

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

No phase Interventional Endometrial Cancer Endometrioid Carcinoma Mismatch Repair Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA).
Who it may be relevant to
Registry conditions: Endometrial Cancer, Endometrioid Carcinoma, Mismatch Repair Deficiency. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Complete remission (CR) rate [Time frame: 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]
Secondary outcome measures (6)
  • Recurrence rate [Time frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR]
  • Pregnancy rate [Time frame: 1 year after CR]
  • Live birth rate [Time frame: 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.]
  • CA125 [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hospital — Beijing

Identifiers

NCT: NCT06549855 · 2024MMRdECFerSp

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗