PD-1 Inhibitor and Progesterone Combination for Fertility Preservation in Women with Early-Stage Mismatch Repair-Deficient Endometrial Cancer

What this Trial Is About

Researchers are investigating the feasibility of combining a PD-1 inhibitor with progesterone to preserve fertility in women with early-stage mismatch repair-deficient MMRd endometrial cancer. This study focuses on patients who wish to maintain their fertility while managing this form of endometrial cancer, which typically requires removal of reproductive organs. The rising incidence of endometrial cancer in younger women and the delay in childbearing age has created a need for fertility-preserving treatments, especially since progesterone therapy alone may have limited efficacy in MMRd cases. Participants receive a combination treatment of a PD-1 inhibitor either Sintilimab or Pembrolizumab administered by intravenous injection every three weeks, along with daily oral progesterone therapy using medroxyprogesterone acetate MPA or megestrol acetate MA. The treatment aims to reverse cancerous changes in the endometrium while preserving fertility. The study monitors patients starting from treatment initiation through an average period of about three months, with longer follow-up to assess recurrence, pregnancy, and live birth rates. During the study, participants undergo regular evaluations including pathological biomarker assessments, CA125 blood tests, and monitoring for adverse reactions at three-month intervals and beyond. The main outcomes measured are complete remission rates and time to remission. Additional outcomes include recurrence rates up to five years after remission, pregnancy and live birth rates one year after remission or pregnancy, and safety monitoring. The total study duration extends with follow-up assessments up to five years to evaluate long-term outcomes of the treatment.

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