Clinical trial NCT06549855: PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer
Official title: PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Endometrioid Carcinoma
Mismatch Repair Deficiency
Keywords: Fertility preservation
Endometrioid Carcinoma
PD-1 inhibitor
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Peking University Third Hospital
name: Huazhong University of Science and Technology
name: Tianjin Medical University
name: Shandong University
name: Shengjing Hospital
name: Beijing Chao Yang Hospital
First posted: 2024-08-12
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Complete remission (CR) rate
timeFrame: From start of treatment to trial completion, an average of 3 months
measure: Time to CR
timeFrame: From start of treatment to trial completion, an average of 3 months
Secondary outcomes:
measure: Recurrence rate
timeFrame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR
measure: Pregnancy rate
timeFrame: 1 year after CR
measure: Live birth rate
timeFrame: 1 year after pregnancy
measure: Pathological biomarker
timeFrame: From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth.
measure: CA125
timeFrame: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
measure: Adverse reactions
timeFrame: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jianliu Wang, Professor
role: STUDY_CHAIR
References: