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Advanced Ovarian CancerPhase 2NCT07120451

Combination Therapy of Senaparib and Bevacizumab for First-line Maintenance Therapy in Newly Diagnosed Advanced Homologous Recombination Proficient Ovarian Cancer Based on Exosome Protein Marker

A Phase 2 study testing Senaparib and Bevacizumab in people with Advanced Ovarian Cancer, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking combination therapy of Senaparib and Bevacizumab is safe and works well for people with first-line maintenance therapy in newly diagnosed advanced homologous recombination proficient ovarian cancer, and… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Advanced Ovarian Cancer
What is being tested?
Senaparib and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
10 Oct 2025to 31 Oct 2028
Phase
Phase 2
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;
  • Age range of 18 to 75 years old (calculated from the day of signing informed consent);
  • Patients with newly diagnosed epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathology;
  • FIGO stage III-IV, stage III subjects must have undergone one optimal tumor reduction surgery (first cell reduction surgery or intermittent cell reduction surgery). Participants in Phase IV studies must have undergone biopsy and/or first-time cytoreductive surgery or intermittent cytoreductive surgery; Can provide 10 pathological white films for subsequent research;
  • Tested as HRP
  • Achieving CR or PR after receiving platinum based treatment; CR refers to measurable and/or unmeasurable lesions without RECIST v1.1 criteria in imaging evaluation, and within the normal range of CA125. PR refers to the achievement of PR according to the RECIST v1.1 standard in imaging evaluation after chemotherapy, or the absence of measurable and/or unmeasurable lesions according to the RECIST v1.1 standard in imaging evaluation, with CA125 higher than the normal range and no sustained increase;
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  • Before treatment, the CA125 test results must meet the following specific criteria:
  • If the first detection value is ≤ the upper limit of normal (ULN), the subjects can be randomly divided into groups without the need for a second sampling; If the first detection value is greater than ULN, a second evaluation must be conducted at least 7 days after the first detection. If the second evaluation value of the subject is higher than the first evaluation value by ≥ 15%, the subject is not eligible for selection; 8. Within 8-12 weeks of the last chemotherapy administration, participants must be enrolled and the trial medication must be started; 9. ECOG score: 0 to 1; 10. The main organ functions are normal and meet the following requirements (no blood components or cell growth factors are allowed to be used within 14 days before enrollment):
  • Blood routine examination: ① Hemoglobin (HB) ≥ 100g/L; ② Absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9/L; ③ Platelet count (PLT) ≥ 1 × 10 ^ 11/L;
  • Blood biochemistry test: ① alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (liver metastasis ≤ 5 × ULN); ② Serum total bilirubin (TBIL) ≤ 1.5 × ULN or direct bilirubin ≤ 1.0 × ULN; ③ Serum creatinine Cr ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 ml/min;
  • Coagulation function test: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; 11. Subjects with fertility are required to use at least one medically approved contraceptive measure (such as intrauterine device or condom) during the study treatment period and within 6 months after the last administration of the trial medication; And the serum HCG test result must be negative within 72 hours before the first administration; And it must be non lactating.

Who cannot join

  • Previous (within 5 years) or concurrent incurable malignant tumors, except for cured skin basal cell carcinoma, thyroid carcinoma, cervical carcinoma in situ, and breast cancer with no recurrence more than 3 years after the completion of radical surgery;
  • Have not previously used PARP inhibitors;
  • Those who are unable to swallow pills normally or have gastrointestinal dysfunction that may affect drug absorption, as determined by researchers;
  • Patients with a history of gastrointestinal perforation or major surgery within 4 weeks prior to the first use of medication; Patients with bleeding or bleeding events ≥ CTCAE grade 3, or with unhealed wounds, ulcers, or fractures;
  • Imaging (CT or MRI) shows tumor invasion of large blood vessels or unclear boundary with blood vessels;
  • Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg);
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  • Urine routine shows that urine protein is ≥ 2+, and it is confirmed that the 24-hour urine protein content is ≥ 1.0 g;
  • Individuals who have experienced intestinal obstruction within the past 3 months;
  • Cancer ascites and pleural effusion with clinical symptoms that require puncture or drainage, or those who have received ascites or pleural effusion drainage within 2 months before the first trial medication;
  • Patients with abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy are allowed to receive low-dose low-molecular-weight heparin or oral aspirin for anticoagulation prevention during the trial period;
  • Those who have used other drugs in clinical trials within the previous 4 weeks;
  • Prior to the first dose of the study drug, individuals who have received CYP3A4 potent inhibitors or CYP3A4 potent inducers (those with a half-life of ≥ 5 after elution from the first dose of the study drug can be enrolled) are not allowed to use CYP3A4 potent inhibitors or CYP3A4 potent inducers during the study period, as outlined in Appendix IV.
  • Participants may receive other systemic anti-tumor treatments during the study period;
  • Individuals known to be allergic to the excipients of Senaparib and Bevacizumab;
  • According to the researchers' assessment, there may be other factors that could lead to the forced termination of this study, such as other serious illnesses (including mental illnesses) requiring concurrent treatment, serious laboratory abnormalities, and family or social factors that could affect the safety of the subjects or the collection of data and samples.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xingzhu Ju, PhD contact

021-64175590

lizfeng1231@163.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xingzhu Ju, PhD, 021-64175590, lizfeng1231@163.com

Other trials in China

About this study

Official title: Combination Therapy of Senaparib and Bevacizumab for First-line Maintenance Therapy in Newly Diagnosed Advanced Homologous Recombination Proficient Ovarian Cancer Based on Exosome Protein Marker: a Single Arm, Prospective Clinical Study

This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking combination therapy of Senaparib and Bevacizumab is safe and works well for people with first-line maintenance therapy in newly diagnosed advanced homologous recombination proficient ovarian cancer, and explore relevant biomarkers for evaluating the efficacy of maintenance therapy through exosome. Researchers will look at the Progression-Free Survival, Overall Survival, safety, and any side effects.

Being tested
Senaparib, Bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07120451
Study groupRoleWhat they receive
Senaparib+BevacizumabExperimentalParticipants will receive Senaparib and Bevacizumab in combination. Senaparib qd for 2 years and Bevacizumab q3w for 15 months.
Receives: Drug: Senaparib; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    Progression-free survival, according to RECIST v1.1

    Measured: approximately 2 years

Secondary outcomes (2)

  1. OS

    Overall survival, according to RECIST v1.1

    Measured: Up to 2 years

  2. AEs

    Adverse Events, according to CTCAE V5.0 criteria, During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event.

    Measured: From the first drug administration to within 30 days for the last treatment dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2025
  2. Study start10 Oct 2025 (estimated)
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07120451
Sponsor's protocol ID
OC-SENABEV-HRP
Status last verified
Aug 2025
First submitted
6 Aug 2025
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data is available per require after approved by ethics broad.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Senaparib and Bevacizumab in people with Advanced Ovarian Cancer, run by Fudan University 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 11 inclusion and 15 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 13 Aug 2025. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Xingzhu Ju, PhD (021-64175590, lizfeng1231@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07120451.

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 13 Aug 2025.

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