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

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

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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Qilu Hospital of Shandong University

  collaborator OTHER

• Hubei Cancer Hospital

  collaborator OTHER

• Anhui Provincial Cancer Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Hunan Province Tumor Hospital

  collaborator OTHER

• First Affiliated Hospital of Suzhou Medical College

  collaborator OTHER

• Shandong Tumor Hospital

  collaborator OTHER

• Chongqing University Cancer Hospital

  collaborator OTHER

• First Affiliated Hospital of Zhongshan Medical University

  collaborator OTHER

• Peking University Shenzhen Hospital

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2025-05-01

Completion

2025-05-01

Countries

• China

Study Locations