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Niraparib + Sintilimab in Recurrent/Advanced Endometrial Cancer
NCT04885413Phase 2
Key facts
- Status
- Unknown
- Start
- Jul 2021
- Primary completion
- Aug 2022
- Countries
- 1
- Sponsor
- Sun Yat-sen University
- Modality
- Small Molecules, Monoclonal Antibodies
- Drugs
- niraparibsintilimab
- Conditions
- endometrial cancer (EC)
01
Overview
Phase 2, open-label, single-arm trial of niraparib and sintilimab in endometrial cancer (EC), sponsored by Sun Yat-sen University. Primary endpoint: Overall Response Rate at 6 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
study arm
Niraparib + Sintilimab
03
Who it enrols
Women aged 18-70 with histologically confirmed recurrent or advanced endometrial epithelial carcinoma who have failed or are intolerant to at least first-line chemotherapy. Patients must have measurable disease, ECOG 0-1, and adequate organ function. Exclusion criteria include prior PARP inhibitor therapy, active autoimmune disease, and uncontrolled brain metastases.
04
Endpoints
Primary
Overall Response Rate
Secondary
Duration of Response
Progression-Free Survival
Overall Survival Rate
Disease Control Rate
Time to Response
Adverse Reaction Rate
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