drugset

drugset / Trial / NCT04815408

PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

NCT04815408 ↗

Phase 2 Unknown 40 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University

RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to validate the efficacy and safety of anti-PD-1 in combination with neoadjuvant chemotherapy in women with advanced ovarian cancer.

Timeline

Start: 2021-04-01
Primary completion: 2023-04-01
Completion: 2025-04-01

Publications

Zhu Y, Fei J, Zhu X, Zhang J, Zhou J, Zhang Z. Efficacy and safety of NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr (NAIVE study) in China: study protocol of an open-label, phase II, randomised controlled trial. BMJ Open. 2025 Feb 5;15(2):e092545. doi: 10.1136/bmjopen-2024-092545.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tislelizumab	Monoclonal antibody	200 mg	—
Background	Carboplatin	Small molecule	5 unknown	—
Background	Paclitaxel	Small molecule	260 mg/m2	—

Indications