RecruitingNCT06279104

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


Sponsor

Tongji Hospital

Enrollment

150 participants

Start Date

Mar 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria1

  • Histological evidence of non-ovarian clear cell carcinoma.

Interventions

DRUGphysician's choice of chemotherapy

physician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma

DRUGimmune checkpoint inhibitor based therapy

immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma


Locations(1)

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

Wuhan, Hubei, China

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NCT06279104


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