Endometrial carcinoma is the most common malignancy of the female reproductive tract. Most
cases are diagnosed at an early stage due to the appearance of symptoms such as
postmenopausal bleeding. However, endometrial carcinoma carries a poor prognosis when it
recurs after previous definitive treatment or when diagnosed at an advanced stage.The 5-year
survival rate for FIGO III is approximately 57-66% and for FIGO IV is approximately
10-20%.The combination of PARPpoly adenosine diphosphate-ribose polymeraseinhibitors and
PD1/PD-L1 has the theoretical support of preclinical molecular biology. In recent years, a
large number of basic studies and preclinical models have confirmed that this combination
therapy has superimposed or even synergistic effects on multiple levels.This study intends to
explore the efficacy and safety of anti-PD-1 antibody combined with niraparib in the
treatment of recurrent or advanced endometrial cancer.
This study is an open, multi-center, prospective single-arm Phase II study to study the
effectiveness of niraparib combined with sintilimab in the treatment of recurrent/advanced
endometrial cancer that has failed or cannot be tolerated by chemotherapy Sex and safety. The
study intends to enroll 37 patients who have undergone histopathologically confirmed
recurrence/advanced endometrial cancer who have experienced first-line and above chemotherapy
failure or intolerance and received niraparib combined with sintilimab for treatment. The
Simon two-stage design is used to estimate the sample size. For the first type of error, the
value of (one-sided) is 0.05, the value of is 0.2, the test power is 0.8, and the ORR of
the second-line chemotherapeutic drug is 15%. It is assumed that the objective population of
niraparib combined with sintilimab in the treatment of the target subject population The
remission rate was 35%. Nine cases were enrolled in the first stage. When the number of
effective cases was 1, the combination therapy was considered to be no better than the
single drug, and the trial was terminated. Otherwise, continue with the enrollment of 25
cases in the second stage. Assuming a loss rate of 10%, 37 subjects are expected to be
enrolled in the trial.
Recurrent/ Advanced Stage Endometrial Cancer Patients
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.