A Single Arm, Exploratory, Multicenter Clinical Study of Fluzopari Combined With Apatinib Neoadjuvant Therapy in Patients With Advanced Non R0 Resectable Ovarian Cancer

Fujian Cancer Hospital1 site in 1 country35 target enrollmentNovember 1, 2022

ConditionsOvarian Cancer

InterventionsFluzopari and apatinib

DrugsFluzopari and apatinib

Overview

Phase: Phase 2
Intervention: Fluzopari and apatinib
Conditions: Ovarian Cancer
Sponsor: Fujian Cancer Hospital
Enrollment: 35
Locations: 1
Primary Endpoint: R0 resection rate
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single arm, multi center, exploratory clinical study to evaluate the efficacy and safety of fluzoparide combined with alpatinib as neoadjuvant therapy in patients with BRCA1/2 gene mutation or HRD gene mutation, advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who can not achieve R0 tumor reduction surgery after imaging evaluation or laparoscopic evaluation .

Registry

clinicaltrials.gov

Start Date

November 1, 2022

End Date

May 31, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Fujian Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female patients aged between 18 and 75 years old;
•Patients received open surgery, laparoscopic surgery, or coarse needle aspiration biopsy and confirmed as high-grade serous or endometrioid ovarian cancer, peritoneal cancer, or fallopian tube cancer (hereinafter referred to as ovarian cancer). FIGO stage III-IV;
•BRCA1/2 gene mutation or HRD gene mutation is confirmed by testing tissue or blood samples;
•According to RECIST 1.1 standard, the patient has at least one target lesion with measurable diameter (the long diameter of CT scan for tumor lesions is ≥ 10mm, the short diameter of CT scan for lymph node lesions is ≥ 15mm, and the scanning thickness is 5mm);
•Judge the patients who cannot achieve R0 tumor reduction or cannot tolerate surgery. The criteria for failing to achieve R0 tumor reduction include but are not limited to:
•(1) Fagotti score ≥ 8; (2) When the laparoscopic evaluation method is difficult to implement, the upper abdomen CT score is ≥ 3 (SUDANCT score);
•The criteria for surgical intolerance are as follows:
•(3) Body mass index: BMI ≥ 40.0; (4) Various chronic diseases; (5) Malnutrition or hypoproteinemia; (6) Moderate to massive ascites;
•ECOG PS 0-1 point;
•The main organs function normally and meet the following standards:

Exclusion Criteria

•Other clinical drug experiments in which other experimental research drugs are used together with the study;
•In addition to this study, use other cancer neoadjuvant therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, microbial therapy, traditional Chinese medicine therapy and other experimental treatments;
•Patients known to be allergic to fluzoparide or allergic to active or non active components of fluzoparide with similar chemical structure;
•Patients known to be allergic to appatinib or allergic to active or inactive components of drugs with similar chemical structure to appatinib;
•It is impossible to swallow the oral drug and any gastrointestinal disease that may interfere with the absorption and metabolism of the study drug, such as uncontrollable nausea and vomiting, gastrointestinal obstruction or malabsorption;
•Have used known or possible PARP inhibitors and anti vascular production inhibitors in the past;
•Symptomatic or uncontrolled brain metastasis requiring simultaneous treatment, including but not limited to surgery, radiotherapy and/or corticosteroids, or clinical manifestations of spinal cord compression;
•Subjects suffered from other malignant diseases in the past 3 years, except skin squamous cell carcinoma, basal like carcinoma, breast intraductal carcinoma in situ or cervical carcinoma in situ;
•The patient was previously or currently diagnosed as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
•Recently (within 3 months), there has been intestinal obstruction and gastrointestinal perforation;

Arms & Interventions

Fluzopari and Apatinib group

Fluzopari and Apatinib were used in patients with newly diagnosed ovarian cancer before any treatment. The daily dose should be strictly controlled according to the experimental design.

Intervention: Fluzopari and apatinib

Outcomes

Primary Outcomes

R0 resection rate

Time Frame: 3-month

The percentage of patients received R0 resection after Fluzopari and Apatinib neoadjuvant treatment.

Overall Response Rate (ORR)

Time Frame: 3-month

ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions.