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Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Participants received Niraparib 200mg or 300mg QD PO continually combined with Yangzheng Xiaoji capsule， 0.36g\*4 tid，28 days as one cycle，up to 3 cycles.

Chinese patent medicine Yangzheng Xiaoji capsule， 0.36g\*4 tid，28 days as one cycle，up to 3 cycles.

Yangzheng Xiaoji

Niraparib 200 or 300mg\* QD PO continually;

\*The starting dose of niraparib was individualized based on patients' bodyweight and baseline platelet count; 200 mg QD for Patients with baseline body weight \<77 kg or platelets count \<150,000/μL;300 mg QD for Patients with baseline body weight ≥77 kg and platelets count ≥150,000/μL.

Guonan Zhang

Hong Liu

Tingyuan Li

This study is an open-label, single-Arm， phase II clinical trial of a Chinese Patent Medicine Yangzheng Xiaoji Capsule to improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

This study will investigate a Chinese Patent Medicine Yangzheng Xiaoji Capsule improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced EOC, who have previously received ≥ 3 cycles of prior combined bevacizumab chemotherapy and a complete or partial response with platinum-based chemotherapy.

Approximately 50 eligible subjects are planned to be enrolled, given Yangzheng Xiaoji Capsule and niraparib maintenance treatment.

The dosing regimen is:Niraparib 200mg QD combined with Yangzheng Xiaoji Capsule 0.36g\*4 tid，28 days/cycle. Subjects will receive Niraparib plus Yangzheng Xiaoji Capsule up to 3 cycles.

A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer

An Open-label, Phase II Clinical Trial of of a Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Adverse Reactions Nausea of Niraparib in in the First-line Maintenance Treatment in Advanced Epithelial Ovarian Cancer (EOC) Patients

Incidence of All Grade Anemia, Thrombocytopenia, Neutropenia within 3 Cycles (CTCAE V5.0)

Incidence of All Grade Fatigue Over 3 Cycles (CTCAE V5.0)

base on Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) score

PFS rate, PFS, OS and overall response rate (ORR, Overall response rate) at 12, 18 and 24 months in patients with advanced ovarian cancer maintained on chemotherapy combined with bevacizumab switched nilaparib

Sichuan Cancer Hospital and Research Institute

Director, Head of Gynecologic Oncology Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer	NCT05641506	Ovarian Cancer	Yangzheng Xiaoj... Niraparib	18 Years -	Sichuan Cancer Hospital and Research Institute
A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer	NCT05641506	Ovarian Cancer	Yangzheng Xiaoj... Niraparib	18 Years -	Sichuan Cancer Hospital and Research Institute

Spots Global Cancer Trial Database for niraparib, ovarian cancer,nausea