Comparing treatments for ovarian clear cell carcinoma patients
A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
This study is testing whether chemotherapy chosen by doctors or a new immune therapy works better for patients with relapsed ovarian clear cell carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | chemotherapy, sintilimab, bevacizumab |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06279104 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of physician's choice of chemotherapy versus immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed or refractory ovarian clear cell carcinoma (OCCC). It will compare real-world treatment responses to those observed in a previous phase II trial involving sintilimab and bevacizumab. The study seeks to answer key questions about the efficacy of these treatment options in a real-world setting, focusing on patient outcomes and survival rates.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 to 75 with a histological diagnosis of ovarian clear cell carcinoma who have undergone at least one line of platinum-containing chemotherapy.
Not a fit: Patients with non-ovarian clear cell carcinoma or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with ovarian clear cell carcinoma.
How similar studies have performed: Previous studies have shown promise in using immune checkpoint inhibitors for ovarian cancer, but this specific comparative approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Qinglei Gao, PhD
- Email: qingleigao@hotmail.com
- Phone: +86 13871127473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.