Epithelial Ovarian CancerNCT06010667
A Prospective, Randomized Controlled Study of Cyclophosphamide, Bevacizumab With or Without Envafolimab in Recurrent Epithelial Ovarian Cancer (EOC), Fallopian Tube Cancer, and Primary Peritoneal Cancer
An observational study of Epithelial Ovarian Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of cyclophosphamide and bevacizumab in combination with Envafolimab in the treatment of recurrent epithelial ovarian cancer (EOC), fallopian tube cancer, and primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Envafolimab
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Aug 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer
Who may be able to join
- Age 18-70 years Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer Patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer following platinum-based chemotherapy measurable lesions (according to RECIST 1.1 criteria, non-lymph node lesions CT scan long diameter ≥ 10 mm, lymph node lesions CT scan short diameter ≥ 15 mm) ECOG PS score: 0 - 1;
Who cannot join
- Subject has prior or concurrent other malignancy Prior treatment with other PD-L1/PD-L1 inhibitors cannot be enrolled; Subject has known previous hypersensitivity to macromolecular protein preparations or applied drug components
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to evaluate the efficacy and safety of cyclophosphamide and bevacizumab in combination with Envafolimab in the treatment of recurrent epithelial ovarian cancer (EOC), fallopian tube cancer, and primary peritoneal cancer.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Envafolimab
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
With or without Envafolimab
| Study group | Role | What they receive |
|---|---|---|
| EBC | cyclophosphamide and bevacizumab in combination with Envafolimab Receives: Drug: Envafolimab | |
| BC | cyclophosphamide in combination with Envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate;ORR
CR+PR
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010667
- Sponsor's protocol ID
- Zhengmao ZHANG
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study of Cyclophosphamide, Bevacizumab With or Without Envafolimab in Recurrent Epithelial Ovarian Cancer (EOC), Fallopian Tube Cancer, and Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT06010667
- Acronym / sponsor ID
- Zhengmao ZHANG
- Conditions
- Epithelial Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 24 Aug 2023 (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 primary objective of this study is to evaluate the efficacy and safety of cyclophosphamide and bevacizumab in combination with Envafolimab in the treatment of recurrent epithelial ovarian cancer (EOC), fallopian tube cancer, and primary peritoneal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBC | – | Drug: Envafolimabcyclophosphamide and bevacizumab in combination with Envafolimab |
| BC | – | –cyclophosphamide in combination with Envafolimab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer
Key inclusion criteria (1 listed)
- Age 18-70 years Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer Patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer following platinum-based chemotherapy measurable lesions (according to RECIST 1.1 criteria, non-lymph node lesions CT scan long diameter ≥ 10 mm, lymph node lesions CT scan short diameter ≥ 15 mm) ECOG PS score: 0 - 1;
Key exclusion criteria (1 listed)
- Subject has prior or concurrent other malignancy Prior treatment with other PD-L1/PD-L1 inhibitors cannot be enrolled; Subject has known previous hypersensitivity to macromolecular protein preparations or applied drug components
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 |
|---|---|---|
| EnvafolimabWith or without Envafolimab | Drug | EBC |
Primary outcome
overall response rate;ORR
Time frame: 2years
CR+PR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
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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 Epithelial Ovarian Cancer, run by Hebei Medical University Fourth 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 1 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 24 Aug 2023. 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 zhengmao zhang, Chief Physician (13933129926, 1356606@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate;ORR (time frame: 2years). 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 24 Aug 2023.