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

Hebei Medical University Fourth Hospital1 site in 1 country60 target enrollmentSeptember 1, 2023

ConditionsEpithelial Ovarian Cancer

InterventionsEnvafolimab

DrugsEnvafolimab

Overview

Phase: Not Applicable
Intervention: Envafolimab
Conditions: Epithelial Ovarian Cancer
Sponsor: Hebei Medical University Fourth Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: overall response rate;ORR
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2023

End Date

August 1, 2026

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hebei Medical University Fourth Hospital

Responsible Party

Sponsor

Eligibility 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