NCT06010667

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2023Aug 2026

First Submitted

Initial submission to the registry

August 20, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 20, 2023

Last Update Submit

August 20, 2023

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • overall response rate;ORR

    CR+PR

    2years

Study Arms (2)

EBC

cyclophosphamide and bevacizumab in combination with Envafolimab

Drug: Envafolimab

BC

cyclophosphamide in combination with Envafolimab

Interventions

EnvafolimabDRUG

With or without Envafolimab

EBC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei

Shijiazhuang, Hebei, 050300, China

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

envafolimab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

zhengmao zhang, Chief Physician

CONTACT

139331299261356606@vip.sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2023

First Posted

August 24, 2023

Study Start

September 1, 2023

Primary Completion

August 1, 2024

Study Completion (Estimated)

August 1, 2026

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)