Peritoneal Adhesion
Conditions
Keywords
bevacizumab, Intraperitoneal administration, Ovarian Cancer, Peritoneal Adhesion
Brief 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.
Interventions
DRUGBevacizumab
Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
DRUGCarboplatin
carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
DRUGpaclitaxel
paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically and radiologically confirmed stage IV or postoperative recurrence ovarian cancer. 2. Age of 18-70, Karnofsky score higher than 80. 3. No severe functional damage of major organ, normal liver and kidney function. 4. Peritoneal adhesion. (1) peritoneal adhesions diagnosed by microlaparoscopy or abdominal operations, and classification according to Nair criteria is performed. (1) must be met. (2) Peritoneal adhesion symptoms, intermittent abdominal pain, abdominal distension, nausea and vomiting, hard to pass stools or gas; (3) Peritoneal adhesion signs，abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4) B ultrasound or CT or MRI show peritoneal adhesion or adhesion-related complications.
Exclusion criteria
1. Complete intestinal obstruction and suitable for surgery. 2. Patients known to be allergic to bevacizumab or any of the components of the drug. 3. Other ongoing anti-tumor treatment. 4. Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure 5. Active wound infection and a history of uncontrolled psychiatric illness. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peritoneal adhesion ORR (pORR) | 3weeks after the last treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) | From first dose up to 1 year | Quality of Life (QoL) assessed by FACT-O |
| Progression free survival (PFS) | Up to 3 years | From randomization until documented progressive disease or death |
| Number of Patients with Adverse Events | From first dose up to 1 month after the last treatment | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| Objective Response Rate (ORR) | Up to 1 year | The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1. |
| Overall survival (OS) | Up to 3 years | From randomization until death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Expression of VEGF-A in peritoneal cavity | Up to 1 year | Quantitation of VEGF-A by enzyme-linked immunosorbent assay (ELISA), before and after intraperitoneal administration. |
Countries
China
Contacts
Primary ContactNan Du, PhD
Outcome results
None listed