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
Sponsor
Hebei Medical University Fourth Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06010667
Collaborator
(none)
60
1
35
1.7
Study Details
Study Description
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 | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated 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
Anticipated Study Start Date
:
Sep 1, 2023
Anticipated Primary Completion Date
:
Aug 1, 2024
Anticipated Study Completion Date
:
Aug 1, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| EBC cyclophosphamide and bevacizumab in combination with Envafolimab |
Drug: Envafolimab
With or without Envafolimab
|
| BC cyclophosphamide in combination with Envafolimab |
Outcome Measures
Primary Outcome Measures
- overall response rate;ORR [2years]
CR+PR
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hebei | Shijiazhuang | Hebei | China | 050300 |
Sponsors and Collaborators
- Hebei Medical University Fourth Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier:
NCT06010667
Other Study ID Numbers:
- Zhengmao ZHANG
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: