A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

• Fluzoparib+Apatinib (Drug): Fluzoparib-Apatinib combination
• Fluzoparib (Drug): Fluzoparib monotherapy
• Fluzoparib+Apatinib (Drug): Fluzoparib-Apatinib combination

Primary outcomes

• (Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle [up to 28 days]
• (Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib [up to 28 days]
• (Phase 2) Objective response rate（ORR） in relapsed ovarian cancer patients [Assessed up to a maximum of 20 months]: Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
• (Exploratory research) Objective response rate（ORR） in relapsed ovarian cancer patients [Assessed up to a maximum of 20 months]: Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment

Secondary outcomes

• AEs+SAEs [from the first drug administration to within 30 days for the last treatment dose]: Adverse Events and Serious Adverse Events
• Progression free survival (PFS) [up to 20 months]: Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment
• Disease control rate (DCR) [up to 20 months]: Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
• Duration of response (DoR) [up to 20 months]: Time from documentation of tumor response to disease progression assessed among patients who had an objective response
• Response rate by RECIST 1.1 criteria [up to 20 months]
• Response rate by GCIG CA125 [up to 20 months]

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

1. Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.
2. Patients must have received at least 2 previous platinum-containing regimens.
3. At least one target lesion.
4. ECOG performance status 0-1.
5. Adequate bone marrow, kidney and liver function.

Exclusion Criteria:

1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ，patients who received PARP inhibitor are eligible;
2. Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed;
3. Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
4. Known to be human immunodeficiency virus positive;
5. Known active hepatitis C virus, or known active hepatitis B virus;
6. Untreated and/or uncontrolled brain metastases;
7. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration;
8. Pregnant or breast-feeding women.