Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| First Hospital of China Medical University | OTHER |
| Cancer Hospital of Xinjiang Medical University | UNKNOWN |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
Not provided
Not provided
Not provided
Not provided
Ovarian cancer is one of the most fatal malignant tumors that threaten women's health. The incidence rate is the third place among the female reproductive system malignant tumors, and the mortality rate ranks the first in gynecologic malignancies, the majority of patients have advanced diseases at the time of diagnosis.
This observational study is to evaluate the safety and efficacy of fluzoparib in ovarian cancer patients under real conditions, especially in various subgroups of ovarian cancer patients, in order to provide information about treatment modes for ovarian cancer patients in real-world diagnosis and treatment, and preliminarily evaluate the pharmacoeconomic of fluzoparib in the treatment of ovarian cancer.
Ovarian cancer is one of the most serious malignant tumors that threaten women's health. The incidence rate is third place in the female reproductive system malignant tumors. The mortality rate ranks the first in gynecologic malignancies, and most of them are advanced at the time of diagnosis. The initial treatment of ovarian cancer is mainly surgery and adjuvant chemotherapy. Although most patients can obtain clinical remission after initial treatment, 70% of patients still relapse within 3 years. Therefore, finding effective drugs to prolong the chemotherapy-free interval and exploring comprehensive treatment schemes to prolong survival is the key to treatment.
In recent years, the advent of poly adenosine diphosphate ribose polymerase inhibitors has brought significant changes to the treatment of ovarian cancer. A series of high-level evidence-based medical evidence shows that the application of PARP inhibitors after complete and partial remission of initial treatment or platinum-sensitive recurrence treatment can significantly prolong the progression-free survival time of ovarian cancer patients, Maintenance therapy has become a new model for the treatment of ovarian cancer. At the same time, PARP inhibitors have been approved for posterior line treatment of ovarian cancer. At present, PARP inhibitors have been widely used in clinics and become an important cornerstone of the comprehensive treatment of ovarian cancer.
Fzocus-2 study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study of fluzoparib in the maintenance treatment of platinum-sensitive recurrent ovarian cancer. The preliminary results were published on the American Society of Gynecological Oncology (SGO) in 2021. A total of 252 patients were included in the study and were treated with fluzoparib (n = 167) or placebo (n = 85). The median follow-up time was 8.5 months. The population-wide data assessed by bIRC showed that the median PFS data were not mature. According to the Kaplan Meier curve, fluzoparib could significantly prolong the PFS (12.9 months: 5.5 months) and reduce the risk of disease progression or death by 75%.
Fzocus-3 is a phase IB study of fluzoparib approved for marketing, which included platinum-sensitive recurrent ovarian cancer patients with germline BRCA mutation who had previously received ≥ 3-line treatment. The objective remission rate of single-drug treatment is as high as 69.9%, and the median progression-free survival time is 12.0 months. It is well comparable with similar drugs and has good safety.
Fluzoparib was approved for the treatment of germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer in December 2020 and maintenance treatment of platinum-sensitive recurrent ovarian cancer in June 2021. A number of studies on fluzoparib in the field of ovarian cancer are also underway. It is urgent to obtain the real-world data of fluzoparib in the field of ovarian cancer in China. This study will collect information on the baseline characteristics, treatment, and management of ovarian cancer provided in the real world to illustrate the safety and effectiveness of fluzoparib in the treatment of ovarian cancer under the conditions of real clinical practice. It may also include various subgroups of patients with ovarian cancer, which are not involved in the existing phase III registered studies, In order to better understand and explore the use of PARP inhibitors in some patient subgroups and the treatment mode and effect of PARP inhibitors in the treatment of this disease.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fluzoparib treatment | patients with Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluzoparib monotherapy or combination therapy | Drug | patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of ≥ grade 3 Hematology related adverse event according to NCI CTCAE v5.0 | the safety of fluzoparib in ovarian cancer under real-world conditions, especially Incidence of Hematology related adverse reactions ≥ grade 3 | 30 days after the last dose of fluzoparib |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of other adverse event according to NCI CTCAE v5.0 | the occasional or rare adverse events of fluzoparib in ovarian cancer under real-world conditions | 30 days after the last dose of fluzoparib |
| overall survival (OS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer had decided to use Fluzoparibb at the time of enrollment in this study
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
| Qingyuan People's Hospital |
| OTHER |
| Zhejiang University | OTHER |
| Panzhihua Central Hospital | OTHER |
| Liangshan First People's Hospital | UNKNOWN |
| Guang'an People's Hospital | UNKNOWN |
| Affiliated Hospital of North Sichuan Medical College | OTHER |
| Cancer Hospital of Guizhou Province | OTHER |
| Guizhou International General Hospital | UNKNOWN |
| Yichang Central People's Hospital | OTHER |
| Wuhan Fourth Hospital | UNKNOWN |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
Not provided
Not provided
Not provided
HRD score and BRCA gene test should be conducted using blood and tumor samples. serum CA125 levels should also be tested.
Overall survival, defined as time from first administration fluzoparib to documented death. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of overall survival (OS) in patients with Ovarian Cancer. Patients will be followed up once 3-6 months at least
| 6 years |
| Progression free survival (PFS) | Progression-free survival, defined as time from first administration fluzoparib to documented disease progression or death from any cause after baseline, whichever occurs first;. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of progression free survival (PFS) in patients with Ovarian Cancer. Patients will be followed up once 3-6 months at least. | 6 years |
| Objective Response Rate (ORR) | Objective Response Rate, defined as percentage of patients with complete or partial response according to local assessments. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of objective response rate (ORR) in patients with Ovarian Cancer. Patients will be followed up once 12 weeks at least. | 6 years |
| Disease Control Rate (DCR) | Disease Control Rate, defined as percentage of patients with complete or partial response or stable disease according to local assessments. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of disease control rate (DCR) in patients with Ovarian Cancer. Patients will be followed up once 12 weeks at least. | 6 years |
| Duration Of Therapy(DOT) | Duration Of Therapy, defined as the time from first administration fluzoparib to the permanent cessation of fluzoparib (including death). | 6 years |
| Tumor marker expression level | Measurements of tumor biomarkers, such as : CA125, HRD, BRCA, etc. | 6 years |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |