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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06010667
Recruitment Status : Not yet recruiting
First Posted : August 24, 2023
Last Update Posted : August 24, 2023
Sponsor:
Information provided by (Responsible Party):
Hebei Medical University Fourth Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Epithelial Ovarian Cancer Drug: Envafolimab

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
EBC
cyclophosphamide and bevacizumab in combination with Envafolimab
 Drug: Envafolimab
With or without Envafolimab
BC
cyclophosphamide in combination with Envafolimab


Outcome Measures
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Primary Outcome Measures :
  1. overall response rate;ORR [ Time Frame: 2years ]
    CR+PR


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06010667


Contacts
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Contact: zhengmao zhang, Chief Physician 13933129926 1356606@vip.sina.com

Locations
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China, Hebei
Hebei
Shijiazhuang, Hebei, China, 050300
Sponsors and Collaborators
Hebei Medical University Fourth Hospital
More Information
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Responsible Party: Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT06010667    
Other Study ID Numbers: Zhengmao ZHANG
First Posted: August 24, 2023    Key Record Dates
Last Update Posted: August 24, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases