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.
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 ≤ 2.
None
Patients with relapsed/persistent OCCC were extracted de-identified, longitudinal electronic health records (EHR)-derived data from 12 tertiary hospitals in China since October 2008. Consecutive patients were enrolled with no restriction on treatment regimens.
Case-only
Retrospective
physician's choice of chemotherapy
Drugphysician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma
immune checkpoint inhibitor based therapy
Drugimmune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma
tumor response rate
The tumor responses to treatment were evaluated by an independent central investigator according to RECIST version 1.1
progression-free survival (PFS)
the time from therapy initiation to the first documented progression or death from any cause, whichever occurred first
time to response (TTR)
the time from therapy initiation to the first documented complete response or partial response
duration of response (DOR)
the time from the first documented response to disease progression or death, whichever occurs first
disease control rate (DCR)
the proportion of patients with complete response, partial response, and stable disease
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Tongji Hospital
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Henan Cancer Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Hubei Cancer Hospital
Collaborator
Anhui Provincial Cancer Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Hunan Province Tumor Hospital
Collaborator
First Affiliated Hospital of Suzhou Medical College
Collaborator
Shandong Tumor Hospital
Collaborator
Chongqing University Cancer Hospital
Collaborator
First Affiliated Hospital of Zhongshan Medical University
Collaborator
Peking University Shenzhen Hospital
Collaborator
