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Recruiting NCT06279104

A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary

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Trial Parameters

Condition Ovarian Clear Cell Carcinoma
Sponsor Tongji Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 150
Sex FEMALE
Min Age 18 Years
Max Age 75 Years
Start Date 2023-03-01
Completion 2025-05-01
Interventions
physician's choice of chemotherapyimmune checkpoint inhibitor based therapy

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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.

Eligibility Criteria

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.

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