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

NCT05641506 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-12-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Yangzheng Xiaoji

Chinese patent medicine Yangzheng Xiaoji capsule， 0.36g\*4 tid，28 days as one cycle，up to 3 cycles.

DRUG

Niraparib

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 & Collaborators

  • Sichuan Cancer Hospital and Research Institute

    lead OTHER

Principal Investigators

  • Guonan Zhang · Sichuan Cancer Hospital and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-10-31
Completion
2025-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641506 on ClinicalTrials.gov