NCT03095001

Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion

Chinese PLA Generation Hospital

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Background: Malignant peritoneal adhesion is a common complication and prognostic factor of ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the recent decade. Malignant peritoneal adhesion is closely associated with the morbidity and mortality of malignant intestinal obstruction. The peritoneal adhesion may aggravates the abdominal symptoms and reduce quality of life. Further, the peritoneal adhesion may impede treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis. Objective: This study aims to treat malignant peritoneal adhesion with the combination of antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the expression of VEGF-A in peritoneal cavity during the treatment.

Conditions

• Peritoneal Adhesion

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
DRUG	Carboplatin	carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
DRUG	paclitaxel	paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2017-03-29
• Last updated: 2017-04-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study