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A Randomized, Open-label, Double-cohort Study of Fluzoparib Combined With Famitinib Malate or SHR-1701 for Neoadjuvant Therapy in Patients With Advanced Ovarian Cancer

NCT07355010 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-01-21

No results posted yet for this study

Summary

This study is a randomized, open-label, double-cohort, national multi-center clinical research. The aim is to evaluate the newly diagnosed FIGO 2014 stage III-IV pathology of neoadjuvant therapy with fluzoparib combined with famitinib or fluzoparib combined with SHR-1701, based on the Fagotti laparoscopy score or upper abdominal Suidan's by the researchers The CT score assesses the efficacy and safety of patients with germline BRCA wild-type ovarian cancer who cannot achieve R0 resection or cannot tolerate initial cytoreductive surgery, as well as the efficacy and safety of surgery, adjuvant therapy, and combined maintenance treatment regimens based on fluzoparib.

The primary endpoint was the objective response rate (ORR) after neoadjuvant therapy as assessed by the researchers based on the RECIST v1.1 criteria. Meanwhile, the chemotherapy response score (CRS), event-free survival (EFS), disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) were also examined. The safety, tolerability and patient-reported outcomes (EQ-5D-5L) of the two cohorts were investigated.

A total of 104 newly diagnosed epithelial ovarian cancer patients with germline BRCA wild-type (FIGO 2014 stage III-IV) are planned to be enrolled.

Conditions

Interventions

DRUG

fuzuloparib

fuzuloparib 150mg bid PO

DRUG

Famitinib

famitinib 10mg qd PO

DRUG

SHR-1701

SHR-1701 1800 mg IV Q3W

Sponsors & Collaborators

  • Qinglei Gao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2028-12-30
Completion
2030-12-30

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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 NCT07355010 on ClinicalTrials.gov