Ovarian Clear Cell Carcinoma
Conditions
Keywords
Ovarian clear cell carcinoma, real world study, immune checkpoint inhibitor
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.
Interventions
DRUGphysician's choice of chemotherapy
physician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma
DRUGimmune checkpoint inhibitor based therapy
immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Henan Cancer Hospital
Qilu Hospital of Shandong University
Hubei Cancer Hospital
Anhui Provincial Cancer Hospital
Peking University Cancer Hospital & Institute
Hunan Province Tumor Hospital
First Affiliated Hospital of Suzhou Medical College
Shandong Tumor Hospital
Chongqing University Cancer Hospital
First Affiliated Hospital of Zhongshan Medical University
Peking University Shenzhen Hospital
Tongji Hospital
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients with age ≥ 18 years old and ≤ 75 years old. 2. There must be a histological diagnosis of ovarian clear cell carcinoma. 3. Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy. 4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2. 5. Expected survival time ≥ 12 weeks.
Exclusion criteria
1.Histological evidence of non-ovarian clear cell carcinoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tumor response rate | 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
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival (PFS) | through study completion, an average of 1 year | the time from therapy initiation to the first documented progression or death from any cause, whichever occurred first |
| time to response (TTR) | through study completion, an average of 3 months | the time from therapy initiation to the first documented complete response or partial response |
| duration of response (DOR) | through study completion, an average of 1 year | the time from the first documented response to disease progression or death, whichever occurs first |
| disease control rate (DCR) | through study completion, an average of 1 year | the proportion of patients with complete response, partial response, and stable disease |
Countries
China
Contacts
Primary ContactQinglei Gao, PhD
Outcome results
None listed