Ovarian Clear Cell CarcinomaNCT06279104
A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
An observational study of Ovarian Clear Cell Carcinoma, run by Tongji Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Clear Cell Carcinoma
- What is being tested?
- physician's choice of chemotherapy and immune checkpoint inhibitor based therapy
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Female patients with age ≥ 18 years old and ≤ 75 years old.
- There must be a histological diagnosis of ovarian clear cell carcinoma.
- Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
- Expected survival time ≥ 12 weeks.
Who cannot join
- 1.Histological evidence of non-ovarian clear cell carcinoma.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qinglei Gao, PhD, MD, +86-13871127473, qingleigao@hotmail.com
Qinglei Gao, PhD, MD
About this study
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
- Ovarian Clear Cell Carcinoma
- Being tested
- physician's choice of chemotherapy, immune checkpoint inhibitor based therapy
- Keywords
- Ovarian clear cell carcinoma, real world study, immune checkpoint inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physician's choice of chemotherapyDrug
physician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma
immune checkpoint inhibitor based therapyDrug
immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma
| Study group | Role | What they receive |
|---|---|---|
| real-world study (RWS)-Chemotherapy | Not described Receives: Drug: physician's choice of chemotherapy | |
| RWS-ICI | Not described Receives: Drug: immune checkpoint inhibitor based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response rate
The tumor responses to treatment were evaluated by an independent central investigator according to RECIST version 1.1
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
progression-free survival (PFS)
the time from therapy initiation to the first documented progression or death from any cause, whichever occurred first
Measured: through study completion, an average of 1 year
time to response (TTR)
the time from therapy initiation to the first documented complete response or partial response
Measured: through study completion, an average of 3 months
duration of response (DOR)
the time from the first documented response to disease progression or death, whichever occurs first
Measured: through study completion, an average of 1 year
disease control rate (DCR)
the proportion of patients with complete response, partial response, and stable disease
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Clear Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Henan Cancer Hospital, Qilu Hospital of Shandong University, Hubei Cancer Hospital, Anhui Provincial Cancer Hospital, Peking University Cancer Hospital & Institute, Hunan Province Tumor Hospital, First Affiliated Hospital of Suzhou Medical College, Shandong Tumor Hospital, Chongqing University Cancer Hospital, First Affiliated Hospital of Zhongshan Medical University, Peking University Shenzhen Hospital
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279104
- Sponsor's protocol ID
- 2023-TJ-OCCC
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The individual participant data will be available (including data dictionaries). The individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices) in particular will be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
- ClinicalTrials.gov ID
- NCT06279104
- Acronym / sponsor ID
- 2023-TJ-OCCC
- Conditions
- Ovarian Clear Cell Carcinoma
- Keywords
- Ovarian clear cell carcinoma, real world study, immune checkpoint inhibitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Henan Cancer Hospital, Qilu Hospital of Shandong University, Hubei Cancer Hospital, Anhui Provincial Cancer Hospital, Peking University Cancer Hospital & Institute, Hunan Province Tumor Hospital, First Affiliated Hospital of Suzhou Medical College, Shandong Tumor Hospital, Chongqing University Cancer Hospital, First Affiliated Hospital of Zhongshan Medical University, Peking University Shenzhen Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real-world study (RWS)-Chemotherapy | – | Drug: physician's choice of chemotherapy |
| RWS-ICI | – | Drug: immune checkpoint inhibitor based therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Female patients with age ≥ 18 years old and ≤ 75 years old.
- There must be a histological diagnosis of ovarian clear cell carcinoma.
- Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
- Expected survival time ≥ 12 weeks.
Key exclusion criteria (1 listed)
- 1.Histological evidence of non-ovarian clear cell carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physician's choice of chemotherapyphysician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma | Drug | real-world study (RWS)-Chemotherapy |
| immune checkpoint inhibitor based therapyimmune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma | Drug | RWS-ICI |
Primary outcome
tumor response rate
Time frame: 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
4 secondary outcomes
progression-free survival (PFS)
Time frame: through study completion, an average of 1 year
time to response (TTR)
Time frame: through study completion, an average of 3 months
duration of response (DOR)
Time frame: through study completion, an average of 1 year
disease control rate (DCR)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Yes. The individual participant data will be available (including data dictionaries). The individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices) in particular will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Clear Cell Carcinoma, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinglei Gao, PhD (+86 13871127473, qingleigao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response rate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.