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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Chinese patent medicine Yangzheng Xiaoji capsule, 0.36g\*4 tid,28 days as one cycle,up to 3 cycles.
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.
Sicchuan cancer hospital
Chengdu, Sichuan, China
Incidence of nausea
all grade of nausea base on CTCAE V5.0
Time frame: 3 cycles (each cycle is 28 days)
Quality of life changes
base on Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) score
Time frame: 3 cycles (each cycle is 28 days)
PFS rate, PFS, OS and overall response rate (ORR, Overall response rate) at 12, 18 and 24 months
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
Time frame: up to 24 months
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