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

Primary Purpose

Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Yangzheng Xiaoji
Niraparib
Sponsored by
Sichuan Cancer Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Niraparib, Ovarian Cancer,Nausea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sicchuan cancer hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of nausea
all grade of nausea base on CTCAE V5.0

Secondary Outcome Measures

Quality of life changes
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
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

Full Information

First Posted
July 5, 2022
Last Updated
November 30, 2022
Sponsor
Sichuan Cancer Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05641506
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Niraparib, Ovarian Cancer,Nausea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Yangzheng Xiaoji
Intervention Description
Chinese patent medicine Yangzheng Xiaoji capsule, 0.36g*4 tid,28 days as one cycle,up to 3 cycles.
Intervention Type
Drug
Intervention Name(s)
Niraparib
Intervention 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.
Primary Outcome Measure Information:
Title
Incidence of nausea
Description
all grade of nausea base on CTCAE V5.0
Time Frame
3 cycles (each cycle is 28 days)
Secondary Outcome Measure Information:
Title
Quality of life changes
Description
base on Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) score
Time Frame
3 cycles (each cycle is 28 days)
Title
PFS rate, PFS, OS and overall response rate (ORR, Overall response rate) at 12, 18 and 24 months
Description
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
Time Frame
up to 24 months
Other Pre-specified Outcome Measures:
Title
Incidence of anemia, thrombocytopenia, and neutropenia
Description
Incidence of All Grade Anemia, Thrombocytopenia, Neutropenia within 3 Cycles (CTCAE V5.0)
Time Frame
3 cycles (each cycle is 28 days)
Title
Incidence of fatigue
Description
Incidence of All Grade Fatigue Over 3 Cycles (CTCAE V5.0)
Time Frame
3 cycles (each cycle is 28 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guonan Zhang
Phone
86-13881866599
Email
zhanggn@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Liu
Phone
86-13693447854
Email
liuhaotian12@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guonan Zhang
Organizational Affiliation
Sichuan Cancer Hospital and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sicchuan cancer hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingyuan Li
Phone
86-18800197211
Email
scchec@163.com
First Name & Middle Initial & Last Name & Degree
Hong Liu
Phone
86-13693447854
Email
liuhaotian12@163.com
First Name & Middle Initial & Last Name & Degree
Guonan Zhang
First Name & Middle Initial & Last Name & Degree
Hong Liu

12. IPD Sharing Statement

Plan to Share IPD
No
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A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer

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