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

NCT ID: NCT06279104

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Clear Cell Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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real-world study (RWS)-Chemotherapy

physician's choice of chemotherapy

Intervention Type DRUG

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

RWS-ICI

immune checkpoint inhibitor based therapy

Intervention Type DRUG

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

Interventions

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physician's choice of chemotherapy

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

Intervention Type DRUG

immune checkpoint inhibitor based therapy

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Hubei Cancer Hospital

OTHER

Sponsor Role collaborator

Anhui Provincial Cancer Hospital

OTHER

Sponsor Role collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Hunan Province Tumor Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Suzhou Medical College

OTHER

Sponsor Role collaborator

Shandong Tumor Hospital

OTHER

Sponsor Role collaborator

Chongqing University Cancer Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Zhongshan Medical University

OTHER

Sponsor Role collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qinglei Gao

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qinglei Gao, PhD

Role: CONTACT

+86 13871127473

Facility Contacts

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Qinglei Gao, PhD, MD

Role: primary

+86-13871127473

Other Identifiers

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2023-TJ-OCCC

Identifier Type: -

Identifier Source: org_study_id

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