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

Tongji Hospital

Status: Enrolling

Conditions: Ovarian Clear Cell Carcinoma

Treatments: Drug: immune checkpoint inhibitor based therapy; Drug: physician's choice of chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06279104

2023-TJ-OCCC

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

real-world study (RWS)-Chemotherapy

Treatment:

Drug: physician's choice of chemotherapy

RWS-ICI

Treatment:

Drug: immune checkpoint inhibitor based therapy