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| Name | Class |
|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| Qilu Hospital of Shandong University | OTHER |
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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:
Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real-world study (RWS)-Chemotherapy |
| ||
| RWS-ICI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physician's choice of chemotherapy | Drug | physician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor response rate | The tumor responses to treatment were evaluated by an independent central investigator according to RECIST version 1.1 | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | the time from therapy initiation to the first documented progression or death from any cause, whichever occurred first | through study completion, an average of 1 year |
| time to response (TTR) |
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Inclusion Criteria:
Exclusion Criteria:
1.Histological evidence of non-ovarian clear cell carcinoma.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinglei Gao, PhD | Contact | +86 13871127473 | qingleigao@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
The individual participant data will be available (including data dictionaries). The individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices) in particular will be shared
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| Hubei Cancer Hospital |
| OTHER |
| Anhui Provincial Cancer Hospital | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Hunan Province Tumor Hospital | OTHER |
| First Affiliated Hospital of Suzhou Medical College | OTHER |
| Shandong Tumor Hospital | OTHER |
| Chongqing University Cancer Hospital | OTHER |
| First Affiliated Hospital of Zhongshan Medical University | OTHER |
| Peking University Shenzhen Hospital | OTHER |
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| immune checkpoint inhibitor based therapy | Drug | immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma |
|
the time from therapy initiation to the first documented complete response or partial response
| through study completion, an average of 3 months |
| duration of response (DOR) | the time from the first documented response to disease progression or death, whichever occurs first | through study completion, an average of 1 year |
| disease control rate (DCR) | the proportion of patients with complete response, partial response, and stable disease | through study completion, an average of 1 year |