A Prospective Observational Study of Senaparib in the Treatment of Epithelial Ovarian Cancer (RESO)

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。

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cancer (OvCa)
• Intervention / Treatment: Drug: Senaparib capsules(20mg)

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Tao Zhu; Phone Number: +86 138 5806 5156; Email: zhutao@zjcc.org.cn
• Study Contact Backup: Name: Ying Li Zhang; Phone Number: +86152 6853 0651

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days after the last dose of fluzoparib

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment patterns of senaparib	the initial dose of senaprib 、incidence of dose reduction of senaparib 、treatment discontinuaiton of senaparib	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.	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.	6 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ovarian cancer; senaparib; real word study
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; senaparib
• Other Study ID Numbers: IRB-2026-348 (IIT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No