Clinical trial NCT06279104: A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
Official title: A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Clear Cell Carcinoma
Keywords: Ovarian clear cell carcinoma
real world study
immune checkpoint inhibitor
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Union Hospital, China
name: Henan Cancer Hospital
name: Qilu Hospital of Shandong University
name: Hubei Cancer Hospital
name: Anhui Provincial Cancer Hospital
name: Peking University Cancer Hospital & Institute
name: Hunan Province Tumor Hospital
name: First Affiliated Hospital of Suzhou Medical College
name: Shandong Tumor Hospital
name: Chongqing University Cancer Hospital
name: First Affiliated Hospital of Zhongshan Medical University
name: Peking University Shenzhen Hospital
First posted: 2024-02-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: tumor response rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: through study completion, an average of 1 year
measure: time to response (TTR)
timeFrame: through study completion, an average of 3 months
measure: duration of response (DOR)
timeFrame: through study completion, an average of 1 year
measure: disease control rate (DCR)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: