A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: physician's choice of chemotherapy, immune checkpoint inhibitor based therapy.
- Who it may be relevant to
- Registry conditions: Ovarian Clear Cell Carcinoma. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug physician's choice of chemotherapy
physician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma - Drug immune checkpoint inhibitor based therapy
immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma
Primary outcome measures
- tumor response rate [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (4)
- progression-free survival (PFS) [Time frame: through study completion, an average of 1 year]
- time to response (TTR) [Time frame: through study completion, an average of 3 months]
- duration of response (DOR) [Time frame: through study completion, an average of 1 year]
- disease control rate (DCR) [Time frame: through study completion, an average of 1 year]
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 ≤ 2.
- Expected survival time ≥ 12 weeks.
Exclusion criteria
1.Histological evidence of non-ovarian clear cell carcinoma.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT06279104 · 2023-TJ-OCCC