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

February 23, 2024 updated by: Qinglei Gao, Tongji Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with relapsed/persistent OCCC were extracted de-identified, longitudinal electronic health records (EHR)-derived data from 12 tertiary hospitals in China since October 2008. Consecutive patients were enrolled with no restriction on treatment regimens.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
real-world study (RWS)-Chemotherapy
Drug: physician's choice of chemotherapy
physician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma
RWS-ICI
Drug: immune checkpoint inhibitor based therapy
immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor response rate
Time Frame: through study completion, an average of 1 year
The tumor responses to treatment were evaluated by an independent central investigator according to RECIST version 1.1
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival (PFS)
Time Frame: through study completion, an average of 1 year
the time from therapy initiation to the first documented progression or death from any cause, whichever occurred first
through study completion, an average of 1 year
time to response (TTR)
Time Frame: through study completion, an average of 3 months
the time from therapy initiation to the first documented complete response or partial response
through study completion, an average of 3 months
duration of response (DOR)
Time Frame: through study completion, an average of 1 year
the time from the first documented response to disease progression or death, whichever occurs first
through study completion, an average of 1 year
disease control rate (DCR)
Time Frame: through study completion, an average of 1 year
the proportion of patients with complete response, partial response, and stable disease
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

Chongqing University Cancer Hospital
Henan Cancer Hospital
Qilu Hospital of Shandong University
Hubei Cancer Hospital
Peking University Cancer Hospital & Institute
Anhui Provincial Cancer Hospital
Wuhan Union Hospital, China
Peking University Shenzhen Hospital
Hunan Province Tumor Hospital
Shandong Tumor Hospital
First Affiliated Hospital of Suzhou Medical College
First Affiliated Hospital of Zhongshan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Estimated)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-TJ-OCCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual participant data will be available (including data dictionaries). The individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices) in particular will be shared

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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