MedTrace Logo

Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

NCT04507841 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-12-17

No results posted yet for this study

Summary

This is a prospective, interventional, single-arm, open-label, phase II study to evaluate the safety and efficacy of niraparib monotherapy as neoadjuvant therapy in patients with advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who had low likelihood of achieving R0 cytoreduction by imaging assessment or laparoscopic evaluation, or cannot tolerate PDS by poor conditions.

Conditions

Interventions

DRUG

Niraparib

Neoadjuvant niraparib monotherapy with an individualized starting dose of 200mg/day or 300mg/day based on body weight or platelet count. The 28-day treatment cycle consists of 21 days of medication followed by a 7-day break. Two cycles of neoadjuvant niraparib monotherapy were used, and the investigator may choose to have an additional cycle based on the patient's condition.

Sponsors & Collaborators

  • West China Second University Hospital

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Renmin Hospital of Wuhan University

    collaborator OTHER

  • Sun Yat-sen University Cancer Center, Sun Yat-sen University

    collaborator UNKNOWN

  • Guangdong Provincial People's Hospital Affiliated to Southern Medical University

    collaborator UNKNOWN

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Qinglei Gao, MD. PhD · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2023-09-25
Completion
2026-12-31

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 NCT04507841 on ClinicalTrials.gov