Trial Title:
Fluzoparib Neoadjuvant Therapy for Ovarian Cancer
NCT ID:
NCT06541314
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fluzoparib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluzoparib
Description:
Fluzoparib (50mg per capsule) 150mg po bid. Take Fluzoparib for 3 weeks, then stop for 1
week, constituting a 28-day cycle. Administer 2 cycles in total.
Arm group label:
Fluzoparib neoadjuvant therapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female patients aged 18-75 years.
2. Biopsies obtained via open surgery, laparoscopic surgery, or needle biopsy,
confirmed by professional pathologists as high-grade serous or endometrioid ovarian
cancer, peritoneal cancer, or fallopian tube cancer (hereinafter referred to as
ovarian cancer); FIGO stage III-IV.
3. Presence of BRCA1/2 mutation or HRD positivity confirmed in tissue or blood samples
by the designated testing institution of the study center.
4. Before any trial procedures begin, an informed consent form must be signed according
to the principle of informed consent and filed at the study center.
5. The patient must have at least one measurable lesion that can be assessed by CT or
MRI (RECIST 1.1).
6. Blood and tissue samples from patients can be obtained before, during, and after
treatment, and subjects agree to submit blood and tissue samples to the central
laboratory for the purpose of expansion research for this trial, including but not
limited to: (1) possible gene-related research; (2) Possible tumor marker-related
research.
7. Patients deemed unable to achieve R0 cytoreduction or unable to tolerate surgery by
gynecologic oncologists at the study center: (1) Fagotti laparoscopic score ≥ 8
points; (2) When laparoscopic assessment is difficult to perform, an upper abdominal
CT score ≥ 3 points may be used. Criteria for determining inability to tolerate
surgery may include: (1) BMI ≥ 40.0; (2) Multiple chronic diseases; (3) Malnutrition
or hypoproteinemia; (4) Moderate to large amounts of ascites; (5) Newly diagnosed
venous thromboembolism; (6) ECOG > 2.
8. Expected survival time > 12 weeks.
9. Patients with an ECOG score of 0-2.
10. 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).
11. For women of reproductive age, a negative blood or urine pregnancy test within one
week prior to enrollment is required, and effective contraceptive measures must be
taken after enrollment, such as using physical barrier methods (condoms) or complete
abstinence. The use of oral, injectable, or implantable hormonal contraceptives is
not permitted. Or women who are not of reproductive age, defined as those who have
naturally entered menopause and have been amenorrheic for over a year, have
undergone surgical sterilization (bilateral oophorectomy, bilateral salpingectomy,
or hysterectomy), or have serum follicle-stimulating hormone, luteinizing hormone,
and plasma estradiol levels within the menopausal range as specified by the study
center laboratory.
12. Understand the trial process and voluntarily sign the informed consent form, with
the ability to comply with the trial protocol for the duration of the study,
including cooperating with any required treatments, examinations, tests, follow-ups,
and questionnaires.
13. Patients are willing to complete quality of life questionnaires during the trial
treatment and follow-up process, and agree that the results of these questionnaires
may be used for clinical research.
14. Any prior chemotherapy-related toxicities must have resolved to ≤ CTCAE grade 1 or
baseline levels, except for stable grade 2 or lower sensory neuropathy or alopecia.
Exclusion Criteria:
1. Concurrent use of other investigational drugs or participation in other clinical
drug trials during this study.
2. Concurrent use of other neoadjuvant treatments for cancer during this study,
including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial
therapy, traditional Chinese medicine, and other experimental therapies.
3. Known allergy to Fluzoparib or any active or inactive components with a similar
chemical structure to Fluzoparib.
4. Unable to swallow oral medications, and having any gastrointestinal disorders that
may interfere with the absorption or metabolism of the study drug, such as
uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption.
5. Received any cancer-related treatment for ovarian cancer.
6. Previously received known or potential PARP inhibitor therapy.
7. Symptomatic or uncontrollable brain metastases requiring concurrent treatment,
including but not limited to surgery, radiation, and/or corticosteroids, or clinical
manifestations of spinal cord compression.
8. History of severe venous thrombosis or pulmonary embolism.
9. Received other molecular targeted therapy within 4 weeks before enrollment.
10. Symptomatic or uncontrollable brain metastases requiring concurrent treatment,
including but not limited to surgery, radiation, and/or corticosteroids, or clinical
manifestations of spinal cord compression.
11. Undergone major surgery within 3 weeks before the start of the study, or not yet
recovered from surgery.
12. Presence of uncorrected electrolyte disturbances at the time of dosing.
13. Subjects have had other malignant diseases in the past 3 years, except for
effectively treated skin squamous cell carcinoma, basal cell carcinoma, ductal
carcinoma in situ of the breast, or cervical carcinoma in situ.
14. Patients have a history of or current diagnosis of myelodysplastic syndrome (MDS) or
acute myeloid leukemia (AML).
15. Patients with severe, uncontrolled diseases or whom the investigator judges to be
generally unsuitable for inclusion in the study, including but not limited to:
active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis
C, etc.; severe cardiovascular diseases, uncontrolled ventricular arrhythmias,
myocardial infarction within the last 3 months; uncontrolled grand mal seizures,
unstable spinal cord compression, superior vena cava syndrome, or other mental
disorders that may affect the patient's ability to sign the informed consent;
uncontrolled hypertension; immunodeficiency (excluding splenectomy) or other
conditions that the investigator considers may expose the patient to high-risk
toxicity.
16. Any medical history or existing clinical evidence suggesting potential confounding
of study results, interference with patient compliance with the study protocol
throughout the study treatment period, or not in the best interest of the patient.
17. The patient received a platelet or red blood cell transfusion within 3 days before
the start of treatment with the study drug.
18. Pregnant or lactating patients, or those planning to become pregnant during the
study treatment period.
19. Clinically unresolved prior treatment toxicity (≥ grade 2), excluding alopecia,
neuropathy, lymphocytopenia, and skin hypopigmentation.
20. Persons involved in the planning or implementation of the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hualei Bu, Dr.
Phone:
+8682165881
Start date:
June 18, 2024
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06541314
