A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib Combined With QL1101 for Maintenance Treatment in Patients With Advanced Epithelial Ovarian Cancer Following Response After First-line Platinum-containing Chemotherapy
Overview
- Phase
- Phase 2
- Intervention
- Fluzoparib
- Conditions
- Ovarian Cancer
- Sponsor
- Yongpeng Wang
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Progression-Free-Survival(PFS)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a Prospective,Single-Center, Single-Arm, Phase 2 study to evaluate the efficacy and safety of Fluzoparib Combined With QL1101, as maintenance treatment, in patients with Advanced FIGO Stage III or IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or primary peritoneal cancer following front-line platinum-based chemotherapy with QL1101. Eligible participants who achieve complete response (CR) or partial response (PR) following treatment with platinum-based chemotherapy in addition to QL1101 will be enrolled in the study and will receive maintenance treatment with fluzoparib (for up to 2 years) combined with QL1101 (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first.
Investigators
Yongpeng Wang
Principal Investigator
Liaoning Tumor Hospital & Institute
Eligibility Criteria
Inclusion Criteria
- •I-1.Patients voluntarily participated in this study and signed the informed consent.
- •I-2.Age 18-70 years, female. I-3.Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •I-4.Patients with newly diagnosed, histologically confirmed, high grade serous or high grade endometrioid ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer（FIGO Stage III or IV）.
- •I-5.Completion of ideal tumor cytoreduction (either intermediate cytoreduction or initial cytoreduction).
- •I-6.First line therapy with platinum-taxane chemotherapy consists of a minimum of 6 treatment cycles and a maximum of 8 treatment cycles in patients who have achieved complete response (CR) or partial response (PR).
- •I-7.Patients who must receive at least 4 cycles of platinum-based therapy if non-hematologic toxicity specifically associated with platinum-based therapy (i.e., neurotoxicity, hypersensitivity reactions, etc.) necessitates early termination.
- •I-8.Those who can swallow tablets normally.
- •I-9.The functions of vital organs meet the following requirements:
- •Absolute neutrophil count ≥ 1.5 × 109/L;
- •Platelets ≥ 90 × 109/L;
Exclusion Criteria
- •E-1.Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
- •E-2.Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma.
- •E-3.Clinical evidence of stable disease or progressive disease following treatment at the end of the first-line chemotherapy.
- •E-4.Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS)Patients with a history of localized malignancy diagnosed over 5 years ago, who have completed all treatment and have no recurrent or metastatic disease prior to enrollment may be enrolled.
- •E-5.Patients with myelodysplastic syndrome/acute myeloid leukemia history. E-6.Patients receiving radiotherapy within 6 weeks or Major surgery within 4 weeks prior to study treatment.
- •E-7.Any previous treatment with PARP inhibitor, including fluzoparib. E-8.Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
- •E-9.Clinically significant (e.g. active) cardiovascular disease, including:
- •New York Heart Association (NYHA) grade 2 or higher heart failure.
- •Unstable angina pectoris.
- •Myocardial infarction within 1 year.
Arms & Interventions
Participants receiving Fluzoparib+ QL1101
Participants will be administered QL1101 7.5 milligram per kilogram (mg/kg) via a 30 minute (min) intravenous (IV) infusion on Day 1 of each 21-day cycle. Fluzoparib will be administered orally twice daily continuously throughout each 21-day cycle. On Day 1 of each cycle, fluzoparib will be administered upon completion of QL1101 infusion. The starting dose of fluzoparib will be based on the participant's Baseline actual body weight or platelet count.
Intervention: Fluzoparib
Participants receiving Fluzoparib+ QL1101
Participants will be administered QL1101 7.5 milligram per kilogram (mg/kg) via a 30 minute (min) intravenous (IV) infusion on Day 1 of each 21-day cycle. Fluzoparib will be administered orally twice daily continuously throughout each 21-day cycle. On Day 1 of each cycle, fluzoparib will be administered upon completion of QL1101 infusion. The starting dose of fluzoparib will be based on the participant's Baseline actual body weight or platelet count.
Intervention: QL1101
Outcomes
Primary Outcomes
Progression-Free-Survival(PFS)
Time Frame: up to 2 years
PFS by investigator's assessment
Secondary Outcomes
- Time to start of first subsequent therapy or death（TFST）(up to 2 years)
- Overall Survival (OS)(up to 2 years)
- Second Progression Free Survival（PFS2）(up to 2 years)
- Health-related quality of life（HRQoL）(up to week 24)