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

Phase 2

Not yet recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: Yangzheng Xiaoji; Drug: Niraparib

• Registration Number: NCT05641506
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

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.

Study Timeline

• Study First Submitted: 2022-07-05
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-30
• Last Update Submitted: 2022-11-30
• Study Start: 2022-12
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07
• Primary Completion: 2023-10
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm	Yangzheng Xiaoji	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.
Arm	Niraparib	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.

Primary Outcome Measures

Name	Time	Method
Incidence of nausea	3 cycles (each cycle is 28 days)	all grade of nausea base on CTCAE V5.0

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sicchuan cancer hospital; 🇨🇳 Chengdu, Sichuan, China