A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
Recruiting now
Conditions studied: Ovarian Clear Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06279104
- Run by
- Tongji Hospital
- People needed
- 150
- Starts
- 2023-03-01
- Expected to finish
- 2025-05-01
- Last updated by the study team
- 2024-08-13
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Expected survival time ≥ 12 weeks.
You may not qualify if…
- Histological evidence of non-ovarian clear cell carcinoma.
Where it is running
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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