- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06010667
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
August 20, 2023 updated by: Hebei Medical University Fourth Hospital
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: zhengmao zhang, Chief Physician
- Phone Number: 13933129926
- Email: 1356606@vip.sina.com
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050300
- Hebei
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
EBC
cyclophosphamide and bevacizumab in combination with Envafolimab
|
With or without Envafolimab
|
BC
cyclophosphamide in combination with Envafolimab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall response rate;ORR
Time Frame: 2years
|
CR+PR
|
2years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2023
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
August 20, 2023
First Submitted That Met QC Criteria
August 20, 2023
First Posted (Actual)
August 24, 2023
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 20, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- Zhengmao ZHANG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epithelial Ovarian Cancer
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Primary Peritoneal Cavity Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial CancerUnited States
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National Cancer Institute (NCI)Gynecologic Oncology GroupCompletedFallopian Tube Cancer | Stage IV Ovarian Epithelial Cancer | Primary Peritoneal Cavity Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial CancerUnited States
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National Cancer Institute (NCI)CompletedRecurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity CancerCanada
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Primary Peritoneal Cavity Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial CancerUnited States
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Life Research Technologies GmbHUnknownOvarian Epithelial CancerAustria, Hungary
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City of Hope Medical CenterNational Cancer Institute (NCI)WithdrawnRecurrent Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IV Ovarian Epithelial Cancer | Stage IV Ovarian Germ Cell Tumor | Recurrent Ovarian Epithelial Cancer | Recurrent Ovarian Germ Cell Tumor | Stage IIIA Ovarian Germ Cell Tumor | Stage IIIB Ovarian Germ Cell... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIIA Primary... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedFallopian Tube Cancer | Peritoneal Cavity Cancer | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial Cancer | Ovarian Mucinous Cystadenocarcinoma and other conditionsUnited States
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