NCT06279104

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Clear Cell Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-02-26
• Last updated: 2024-08-13

Locations

1 site across 1 country: China