RecruitingPhase 2Phase 3NCT07472140

PARP (Poly (ADP-ribose) Polymerase) Inhibitor With or Without Angiogenesis Inhibitor in Homologous Recombination Deficient Primary Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer

To Develop and Implement The Scope of Medical Care for Homologous Recombination Deficient Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer of the III-IV Stages Using Maintenance Therapy With PARP Inhibitor Combined With Angiogenesis Inhibitor.

Sponsor

N.N. Alexandrov National Cancer Centre

Enrollment

120 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancers

Summary

This is a randomized trial evaluating the results of using of PARP inhibitor combined with angiogenesis inhibitor. in patients with homologous recombination deficient primary ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer of the III-IV stages.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

Age ≥18-≤75 years.
Histologically confirmed diagnosis of serous or endometrioid high-grade ovarian cancer, fallopian-tube cancer or primary peritoneal cancer.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Possibility of performing diagnostic laparoscopy or cytoreductive surgery.
Presence of homologous recombination deficiency (HRD).
No contraindications to chemotherapy, or bevacizumab.
Signed informed consent to participate in the study.

Exclusion Criteria3

Presence of another active malignant invasive neoplasm.
Pregnancy or lactation period.
Disease progression during treatment.

Interventions

DRUGPARP inhibitor + Bevacizumab

Patients will receive 6 courses of chemotherapy according to the regimen of platinum drug + paclitaxel + bevacizumab (≥3 cycles) every 21 days. In case of a complete or partial response maintenance therapy is carried out until disease progression or intolerable toxicity or for 2 years to the regimen of PARP inhibitor + bevacizumab.

DRUGPARP inhibitor

Patients will receive 6 courses of chemotherapy according to the regimen of platinum drug + paclitaxel every 21 days. In case of a complete or partial response maintenance therapy of PARP inhibitor is carried out until disease progression or intolerable toxicity or for 2 years.