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

Recruiting

• Conditions: Ovarian Clear Cell Carcinoma
• Interventions: Drug: immune checkpoint inhibitor based therapy; Drug: physician's choice of chemotherapy

• Registration Number: NCT06279104
• Lead Sponsor: Tongji Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-02-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-11
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RWS-ICI	immune checkpoint inhibitor based therapy	-
real-world study (RWS)-Chemotherapy	physician's choice of chemotherapy	-

Primary Outcome Measures

Name	Time	Method
tumor response rate	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China