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Trial Title:
A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
NCT ID:
NCT06279104
Condition:
Ovarian Clear Cell Carcinoma
Conditions: Official terms:
Carcinoma
Adenomyoepithelioma
Adenocarcinoma, Clear Cell
Carcinoma, Ovarian Epithelial
Immune Checkpoint Inhibitors
Conditions: Keywords:
Ovarian clear cell carcinoma
real world study
immune checkpoint inhibitor
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
physician's choice of chemotherapy
Description:
physician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma
Arm group label:
real-world study (RWS)-Chemotherapy
Intervention type:
Drug
Intervention name:
immune checkpoint inhibitor based therapy
Description:
immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell
carcinoma
Arm group label:
RWS-ICI
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
Qinglei Gao, PhD, MD
Phone:
+86-13871127473
Email:
qingleigao@hotmail.com
Investigator:
Last name:
Qinglei Gao, PhD, MD
Email:
Principal Investigator
Start date:
March 1, 2023
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Henan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Hubei Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Anhui Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Hunan Province Tumor Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Suzhou Medical College
Agency class:
Other
Collaborator:
Agency:
Shandong Tumor Hospital
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Zhongshan Medical University
Agency class:
Other
Collaborator:
Agency:
Peking University Shenzhen Hospital
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06279104
