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

Conditions

• Recurrent/ Advanced Stage Endometrial Cancer Patients

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Niraparib in Combination With Anti-PD1 Antibody — DRUG
  Sintilimab： 200mg i.v., d1, 21days one cycle Niraparib： 200mg p.o qd，d1-d21, 21days one cycle

Study Details

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 PARP（poly adenosine diphosphate-ribose polymerase）inhibitors 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.

Key Dates

Start date

Jul 1, 2021

Status verified

Aug 2021

Primary completion

Aug 30, 2022

Completion

Jun 1, 2023

Study Design

Enrollment

37 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: study arm
  Sintilimab： 200mg i.v., d1, 21days one cycle Niraparib： 200mg p.o qd，d1-d21, 21days one cycle

Primary Outcome Measure

Overall respond rate [ Time Frame: at 6 months ]