Clinical trial NCT05641506: A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Niraparib, Ovarian Cancer,Nausea
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of nausea
timeFrame: 3 cycles (each cycle is 28 days)
Secondary outcomes:
measure: Quality of life changes
timeFrame: 3 cycles (each cycle is 28 days)
measure: PFS rate, PFS, OS and overall response rate (ORR, Overall response rate) at 12, 18 and 24 months
timeFrame: up to 24 months
Other outcomes:
measure: Incidence of anemia, thrombocytopenia, and neutropenia
timeFrame: 3 cycles (each cycle is 28 days)
measure: Incidence of fatigue
timeFrame: 3 cycles (each cycle is 28 days)
Locations:
city: Chengdu
country: China
facility: Sicchuan cancer hospital
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: Guonan Zhang
role: PRINCIPAL_INVESTIGATOR
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