Not yet recruitingNCT06010667Updated Aug 24, 2023

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

An observational study in Epithelial Ovarian Cancer, sponsored by Hebei Medical University Fourth Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-24.

Sponsored by Hebei Medical University Fourth Hospital · Observational

From the registry’s dates

Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 60
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Epithelial Ovarian Cancer

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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 60 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Hebei Medical University Fourth Hospital is the lead sponsor of 78 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

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

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 60 participants (estimated)
Patient registry: No

Groups and cohorts

EBC
cyclophosphamide and bevacizumab in combination with Envafolimab
Drug: Envafolimab
BC
cyclophosphamide in combination with Envafolimab

Interventions

DrugEnvafolimab
With or without Envafolimab

What researchers measure

Primary outcomes

overall response rate;ORR
CR+PR
Time frame: 2years

Study locations

1 site

Hebei
Shijiazhuang, Hebei 050300, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06010667
Lead sponsor: Hebei Medical University Fourth Hospital
Responsible party: Sponsor
First posted: Aug 24, 2023
Start date: Sep 1, 2023 (estimated)
Primary completion: Aug 1, 2024 (estimated)
Completion: Aug 1, 2026 (estimated)
Last update: Aug 24, 2023

Study contacts

zhengmao zhang, Chief Physician

Contact

1356606@vip.sina.com

13933129926

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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