Ovarian Cancer (OvCa)RESONCT07586449
A Prospective Observational Study of Senaparib in the Treatment of Epithelial Ovarian Cancer
An observational study of Ovarian Cancer (OvCa), run by Zhejiang Cancer Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer (OvCa)
- What is being tested?
- Senaparib capsules(20mg)
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 31 Dec 2030
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer had decided to use senaparib at the time of enrollment in this study
Who may be able to join
- Sign informed consent and voluntarily join the study;
- Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed by histology or cytology;
- -≥ 18 years old;
- The investigator determined that the patient could receive senaparib monotherapy or combination therapy;
- For patients with fertility, effective contraceptive methods should be used during the study period and within 90 days after the last administration of senaparib
Who cannot join
- There is evidence that the patient is a pregnant or lactating woman;
- Participating in any research with intervention measures other than routine -clinical practice;
- The researcher judges other situations that are not suitable for inclusion in the study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ying Li Zhang contact
About this study
Official title: Evaluation of Safety and Effectiveness of Senaparib in Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer: A Prospective Observational Real-World Study
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 senaparib 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。
Read the detailed 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.
FLAMES study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study of senaparib in the maintenance treatment of advanced ovarian cancer. The preliminary results were published on the American Society of Gynecological Oncology (SGO) in 2023. A total of 404 patients were included in the study and were treated with senaparib (n =271 ) or placebo (n =133 ). The median follow-up time was 22.3months. The population-wide data assessed by BIRC showed that the median PFS data were not reached. According to the Kaplan Meier curve, senaparib could significantly prolong the PFS (NR vs 13.6 months) and reduce the risk of disease progression or death by 57%.
Senaparib was approved for the maintenance treatment of advanced ovarian cancer in January 2025 . A number of studies on senaparib in the field of ovarian cancer are also underway. It is urgent to obtain the real-world data of senaparib 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 senaparib 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.
- Conditions
- Ovarian Cancer (OvCa)
- Being tested
- Senaparib capsules(20mg)
- Keywords
- senaparib, real word study, ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senaparib capsules(20mg)Drug
senaparib monotherapy or combination therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment-Related Adverse Events (TRAEs) according to NCI CTCAE v5.0
Incidence and severity of Treatment-Related Adverse Events (TRAEs) as assessed by the investigator.
Measured: 30 days after the last dose of fluzoparib
Secondary outcomes (3)
treatment patterns of senaparib
the initial dose of senaprib 、incidence of dose reduction of senaparib 、treatment discontinuaiton of senaparib
Measured: 2 years
Progression free survival (PFS)
Progression-free survival, defined as time from first administration senaparib to documented disease progression or death from any cause after baseline, whichever occurs first;. To assess clinical effectiveness of senaparib 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.
Measured: 6 years
overall survival (OS)
Overall survival, defined as time from first administration senaparib to documented death. To assess clinical effectiveness of senaprib 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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start10 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer (OvCa)Studies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Zhu, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586449
- Sponsor's protocol ID
- IRB-2026-348 (IIT)
- Acronym
- RESO
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Effectiveness of Senaparib in Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer: A Prospective Observational Real-World Study
- ClinicalTrials.gov ID
- NCT07586449
- Acronym / sponsor ID
- RESO / IRB-2026-348 (IIT)
- Conditions
- Ovarian Cancer (OvCa)
- Keywords
- senaparib, real word study, ovarian cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 senaparib 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。
Detailed 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.
FLAMES study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study of senaparib in the maintenance treatment of advanced ovarian cancer. The preliminary results were published on the American Society of Gynecological Oncology (SGO) in 2023. A total of 404 patients were included in the study and were treated with senaparib (n =271 ) or placebo (n =133 ). The median follow-up time was 22.3months. The population-wide data assessed by BIRC showed that the median PFS data were not reached. According to the Kaplan Meier curve, senaparib could significantly prolong the PFS (NR vs 13.6 months) and reduce the risk of disease progression or death by 57%.
Senaparib was approved for the maintenance treatment of advanced ovarian cancer in January 2025 . A number of studies on senaparib in the field of ovarian cancer are also underway. It is urgent to obtain the real-world data of senaparib 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 senaparib 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer had decided to use senaparib at the time of enrollment in this study
Key inclusion criteria (5 listed)
- Sign informed consent and voluntarily join the study;
- Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed by histology or cytology;
- -≥ 18 years old;
- The investigator determined that the patient could receive senaparib monotherapy or combination therapy;
- For patients with fertility, effective contraceptive methods should be used during the study period and within 90 days after the last administration of senaparib
Key exclusion criteria (3 listed)
- There is evidence that the patient is a pregnant or lactating woman;
- Participating in any research with intervention measures other than routine -clinical practice;
- The researcher judges other situations that are not suitable for inclusion in the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senaparib capsules(20mg)senaparib monotherapy or combination therapy | Drug | – |
Primary outcome
Incidence and severity of Treatment-Related Adverse Events (TRAEs) according to NCI CTCAE v5.0
Time frame: 30 days after the last dose of fluzoparib
Incidence and severity of Treatment-Related Adverse Events (TRAEs) as assessed by the investigator.
3 secondary outcomes
treatment patterns of senaparib
Time frame: 2 years
Progression free survival (PFS)
Time frame: 6 years
overall survival (OS)
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Li Zhang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer (OvCa), run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Zhu (+86 138 5806 5156, zhutao@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment-Related Adverse Events (TRAEs) according to NCI CTCAE v5.0 (time frame: 30 days after the last dose of fluzoparib). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.