An Open-label, Single Arm, Phase II Trial of Niraparib in Combination With Anti-PD1?Programmed Cell Death Protein 1? Antibody in Recurrent/ Advanced Stage Endometrial Cancer Patients

Summary

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Description

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 ...

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.

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