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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles
First Affiliated Hospital, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeritoneal adhesion ORR (pORR)
Degree of adhesion was measured according to NAIR's criteria by laparoscopy. Grade 0 corresponded to no adhesions, Grade 1 and 2 corresponded to filmy adhesions and grade 3 and 4 to dense adhesions. No adhesions is defined as CR, dense adhesions change to filmy adhesions is defined as PR. The total efficiency ORR was calculated by taking the sum of CR+PR.
Time frame: 3weeks after the last treatment
Number of Patients with Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From first dose up to 1 month after the last treatment
Quality of Life (QoL)
Quality of Life (QoL) assessed by FACT-O
Time frame: From first dose up to 1 year
Progression free survival (PFS)
From randomization until documented progressive disease or death
Time frame: Up to 3 years
Overall survival (OS)
From randomization until death
Time frame: Up to 3 years
Objective Response Rate (ORR)
The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1.
Time frame: Up to 1 year
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