Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05206890 |
| Other study ID # |
2022-TJ-FLU |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 14, 2022 |
| Est. completion date |
December 31, 2032 |
Study information
| Verified date |
January 2022 |
| Source |
Tongji Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
Description:
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.
