Clinical trial · Observational
A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Clear Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immune checkpoint inhibitor based therapy | Drug | — | UNRESOLVED |
| physician's choice of chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- real-world study (RWS)-Chemotherapy
- interventionNames
- Drug: physician's choice of chemotherapy
- label
- RWS-ICI
- interventionNames
- Drug: immune checkpoint inhibitor based therapy
Primary outcomes (1)
- measure
- tumor response rate
- timeFrame
- through study completion, an average of 1 year
- description
- The tumor responses to treatment were evaluated by an independent central investigator according to RECIST version 1.1
Secondary outcomes (4)
- measure
- progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available