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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorTongji Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • physician's choice of chemotherapy
  • immune checkpoint inhibitor based therapy

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tongji Hospital

Lead sponsor

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

Collaborator

Henan Cancer Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

Hubei Cancer Hospital

Collaborator

Anhui Provincial Cancer Hospital

Collaborator

Peking University Cancer Hospital & Institute

Collaborator

Hunan Province Tumor Hospital

Collaborator

First Affiliated Hospital of Suzhou Medical College

Collaborator

Shandong Tumor Hospital

Collaborator

Chongqing University Cancer Hospital

Collaborator

First Affiliated Hospital of Zhongshan Medical University

Collaborator

Peking University Shenzhen Hospital

Collaborator