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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Yangzheng Xiaoji
* Drug: Niraparib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign a written informed consent form before conducting any research-related procedures; Women aged 18 or above; Ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed histologically can be treated with Niraparib after evaluation by clinicians; Life expectancy > 3 months; Patients' ECOG physical condition score is 0-1, KPS score is ≥70; Patients received ≥ 3 cycles bevacizumab in combination within platinum-based chemotherapy Good organ function, including: Neutrophil count ≥ 1500/L Platelet ≥ 100,000/L Hemoglobin ≥10g/dL Serum creatinine ≤1.5 times the upper limit of normal value, or creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation) Total bilirubin ≤1.5 times the upper limit of normal value or direct bilirubin ≤1.0 times the upper limit of normal value AST and ALT ≤2.5 times the upper limit of normal value, and liver metastasis must be ≤5 times the upper limit of normal value. 7. No serious abnormalities of heart, brain, lung, liver and kidney function; 8. No serious mental illness; 9. Ability to comply with the plan; 10. the toxic and side effects of any previous chemotherapy have recovered to ≤CTCAE 1 grade or baseline level, except for sensory neuropathy or alopecia with stable symptoms ≤CTCAE 2 grade. Exclusion Criteria: People who are allergic to the ingredients in Yangzhengxiaoji Capsule Have undergone major surgery within 3 weeks before the start of the study, or have not recovered any surgical effects after surgery, or have received chemotherapy. patients who are combined with other cancers; Patients with severe heart, liver, kidney and hematopoietic diseases; 5 Patients with poor compliance cannot take drugs according to regulations.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm<br>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. | Drug: Yangzheng Xiaoji<br>* Chinese patent medicine Yangzheng Xiaoji capsule， 0.36g*4 tid，28 days as one cycle，up to 3 cycles.<br>Drug: Niraparib<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nausea | all grade of nausea base on CTCAE V5.0 | 3 cycles (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life changes | base on Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) score | 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 | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Niraparib, Ovarian Cancer,Nausea