OncoMatch/Clinical Trials/NCT06541314

Fluzoparib Neoadjuvant Therapy for Ovarian Cancer

Is NCT06541314 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fluzoparib for ovarian cancer.

Phase 2RecruitingQilu Hospital of Shandong UniversityNCT06541314Data as of May 2026

Treatment: Fluzoparib — 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.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Biomarker criteria

Required: BRCA1 mutation

Required: BRCA2 mutation

Disease stage

Required: Stage III, IV

Grade: high-grade

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: any cancer-related treatment for ovarian cancer

Received any cancer-related treatment for ovarian cancer

Cannot have received: PARP inhibitor

Previously received known or potential PARP inhibitor therapy

Cannot have received: molecular targeted therapy

Received other molecular targeted therapy within 4 weeks before enrollment

Lab requirements

Blood counts

NEUT ≥ 1.5×10^9/L; PLT ≥ 100×10^9/L; HGB ≥ 100g/L

Kidney function

serum creatinine ≤ 1.5x ULN, or creatinine clearance rate ≥ 60 mL/min (Cockcroft-Gault)

Liver function

TBIL ≤ 1.5x ULN or DBIL ≤ 1.0x ULN; AST and ALT ≤ 2.5x ULN (≤ 5x ULN with liver metastasis)

Good organ function. (1) Bone marrow function: NEUT ≥ 1.5×10^9/L; PLT ≥ 100×10^9/L; HGB ≥ 100g/L. (2) Liver function: TBIL ≤ 1.5 times the upper limit of normal or DBIL ≤ 1.0 times the upper limit of normal; AST and ALT ≤ 2.5 times the upper limit of normal, and in the presence of liver metastasis, must be ≤ 5 times the upper limit of normal. (3) Renal function: serum creatinine ≤ 1.5 times the upper limit of normal, or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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