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Trial Title:
A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer
NCT ID:
NCT05641506
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Nausea
Niraparib
Conditions: Keywords:
Niraparib, Ovarian Cancer,Nausea
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Yangzheng Xiaoji
Description:
Chinese patent medicine Yangzheng Xiaoji capsule， 0.36g*4 tid，28 days as one cycle，up to
3 cycles.
Arm group label:
Arm
Intervention type:
Drug
Intervention name:
Niraparib
Description:
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.
Arm group label:
Arm
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sicchuan cancer hospital
Address:
City:
Chengdu
Zip:
610000
Country:
China
Contact:
Last name:
Tingyuan Li
Phone:
86-18800197211
Email:
scchec@163.com
Contact backup:
Last name:
Hong Liu
Phone:
86-13693447854
Email:
liuhaotian12@163.com
Investigator:
Last name:
Guonan Zhang
Email:
Principal Investigator
Investigator:
Last name:
Hong Liu
Email:
Sub-Investigator
Start date:
December 2022
Completion date:
May 2025
Lead sponsor:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Source:
Sichuan Cancer Hospital and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05641506
