RecruitingPhase 2NCT06541314

Fluzoparib Neoadjuvant Therapy for Ovarian Cancer

A Multicenter, Single-Arm Clinical Study of Fluzoparib Monotherapy As Neoadjuvant Treatment for Advanced Epithelial Ovarian Cancer


Sponsor

Qilu Hospital of Shandong University

Enrollment

48 participants

Start Date

Jun 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is an interventional, single-arm, open-label clinical trial. To evaluate the safety and efficacy of Fluzoparib as neoadjuvant therapy in patients with FIGO stage III and IV , BRCA mutations or HRD positive epithelial ovarian cancer who cannot achieve R0 surgery as assessed by imaging (Suidan's CT score) or laparoscopy (Fagotti score), or cannot tolerate surgery.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing fluzoparib — a type of drug called a PARP inhibitor that blocks cancer cells' ability to repair their own DNA — as a treatment given before surgery (neoadjuvant therapy) for people with high-grade ovarian, fallopian tube, or peritoneal cancer that carry certain genetic mutations (BRCA1/2 or HRD). The goal is to shrink the tumor before surgery. **You may be eligible if...** - You are a woman aged 18–75 with high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer at FIGO stage III or IV - Your tumor or blood tests confirm a BRCA1/2 mutation or HRD (homologous recombination deficiency) positivity - You have at least one measurable tumor on imaging - You have not started cancer treatment yet **You may NOT be eligible if...** - Your cancer does not have a BRCA or HRD mutation - You have already started chemotherapy or other cancer treatment - You have serious medical conditions that would prevent safe participation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluzoparib

Fluzoparib (50mg per capsule) 150mg po bid, with a treatment cycle of 28 days. Administer 2 cycles in total.


Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT06541314


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