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

Ovarian Clear Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279104
• Other study ID #: 2023-TJ-OCCC
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: February 2024
• Source: Tongji Hospital
• Contact: Qinglei Gao, PhD
• Phone: +86 13871127473
• Email: qingleigao[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Ovarian Clear Cell Carcinoma

Intervention

Drug:
• physician's choice of chemotherapy
physician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma
• immune checkpoint inhibitor based therapy
immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (13)

Lead Sponsor

Collaborator

Tongji Hospital

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response rate	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	progression-free survival (PFS)	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
Secondary	time to response (TTR)	the time from therapy initiation to the first documented complete response or partial response	through study completion, an average of 3 months
Secondary	duration of response (DOR)	the time from the first documented response to disease progression or death, whichever occurs first	through study completion, an average of 1 year
Secondary	disease control rate (DCR)	the proportion of patients with complete response, partial response, and stable disease	through study completion, an average of 1 year