A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
Overview
- Phase
- Not Applicable
- Intervention
- physician's choice of chemotherapy
- Conditions
- Ovarian Clear Cell Carcinoma
- Sponsor
- Tongji Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- tumor response rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:
- What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?
- Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?
- Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?
Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data.
Investigators
Qinglei Gao
Prof.
Tongji Hospital
Eligibility Criteria
Inclusion Criteria
- •Female patients with age ≥ 18 years old and ≤ 75 years old.
- •There must be a histological diagnosis of ovarian clear cell carcinoma.
- •Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤
- •Expected survival time ≥ 12 weeks.
Exclusion Criteria
- •1.Histological evidence of non-ovarian clear cell carcinoma.
Arms & Interventions
real-world study (RWS)-Chemotherapy
Intervention: physician's choice of chemotherapy
RWS-ICI
Intervention: immune checkpoint inhibitor based therapy
Outcomes
Primary Outcomes
tumor response rate
Time Frame: through study completion, an average of 1 year
The tumor responses to treatment were evaluated by an independent central investigator according to RECIST version 1.1
Secondary Outcomes
- progression-free survival (PFS)(through study completion, an average of 1 year)
- time to response (TTR)(through study completion, an average of 3 months)
- duration of response (DOR)(through study completion, an average of 1 year)
- disease control rate (DCR)(through study completion, an average of 1 year)