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Trial 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
NCT ID:
NCT06010667
Condition:
Epithelial Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Envafolimab
Description:
With or without Envafolimab
Arm group label:
EBC
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.
Criteria for eligibility:
Study pop:
epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hebei
Address:
City:
Shijiazhuang
Zip:
050300
Country:
China
Start date:
September 1, 2023
Completion date:
August 1, 2026
Lead sponsor:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Hebei Medical University Fourth Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06010667