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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
1. Sintilimab or Pembrolizumab 200mg intravenous injection, every 3 weeks 2. MA, 320mg/MPA, 500mg, po, once a day
Peking University People's Hospital
Beijing, Beijing Municipality, China
Complete remission (CR) rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor
Time frame: 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
Time frame: From start of treatment to trial completion, an average of 3 months
Recurrence rate
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences.
Time frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR
Pregnancy rate
A pregnancy test shows pregnancy after CR.
Time frame: 1 year after CR
Live birth rate
The live birth rate is defined as the ratio of live births to pregnancies.
Time frame: 1 year after pregnancy
Pathological biomarker
pathological markers(such as Ki-67, estrogen receptor, progesterone receptor, p53, PTEN, MLH1, PMS2, MSH2, and MSH6) at each hysteroscopy
Time frame: From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth.
CA125
Used as a tumor marker for disease monitoring
Time frame: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
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Adverse reactions
Any unfavorable response resulting from the administration of any pharmaceutical agent utilized as part of the therapeutic regimen.
Time frame: From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.