Ovarian Cancer
Conditions
Keywords
Niraparib, Ovarian Cancer,Nausea
Brief summary
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
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.
Interventions
DRUGYangzheng Xiaoji
Chinese patent medicine Yangzheng Xiaoji capsule， 0.36g\*4 tid，28 days as one cycle，up to 3 cycles.
DRUGNiraparib
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.
Sponsors
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Sign a written informed consent form before conducting any research-related procedures; 2. Women aged 18 or above; 3. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed histologically can be treated with Niraparib after evaluation by clinicians; 4. Life expectancy \> 3 months; 5. Patients' ECOG physical condition score is 0-1, KPS score is ≥70; 6. Patients received ≥ 3 cycles bevacizumab in combination within platinum-based chemotherapy 7. 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
1. People who are allergic to the ingredients in Yangzhengxiaoji Capsule 2. 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. 3. patients who are combined with other cancers; 4. Patients with severe heart, liver, kidney and hematopoietic diseases; 5 Patients with poor compliance cannot take drugs according to regulations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of nausea | 3 cycles (each cycle is 28 days) | all grade of nausea base on CTCAE V5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life changes | 3 cycles (each cycle is 28 days) | 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 | up to 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of anemia, thrombocytopenia, and neutropenia | 3 cycles (each cycle is 28 days) | Incidence of All Grade Anemia, Thrombocytopenia, Neutropenia within 3 Cycles (CTCAE V5.0) |
| Incidence of fatigue | 3 cycles (each cycle is 28 days) | Incidence of All Grade Fatigue Over 3 Cycles (CTCAE V5.0) |
Countries
China
Contacts
Primary ContactGuonan Zhang
Backup ContactHong Liu
Outcome results
None listed