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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorZhejiang Cancer Hospital

About this trial

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。

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign informed consent and voluntarily join the study;

Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed by histology or cytology;

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

Disqualifiers

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 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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Senaparib capsules(20mg)

    Drug

    senaparib monotherapy or combination therapy

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
30 days after the last dose of fluzoparib

Secondary outcomes

1

treatment patterns of senaparib

the initial dose of senaprib 、incidence of dose reduction of senaparib 、treatment discontinuaiton of senaparib

Time frame
2 years
2

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.

Time frame
6 years
3

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.

Time frame
6 years

Other outcomes

Sponsors and contacts

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