Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites (NCT01852409) | Clinical Trial Compass
UnknownPhase 1
Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites
China18 participantsStarted 2013-05
Plain-language summary
Malignant ascites often has a profound impact on the quality of life of cancer patients. Current treatments,including dietary, medical, and procedural are often temporary and unsatisfactory options in patients approaching the end of life. Intraperitoneal bevacizumab for the palliation of malignant ascites might be a novel choice for refractory malignant ascites.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form;
✓. Histologically or cytologically confirmed non-squamous cell carcinoma，including colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer, bile duct cancer, ovarian cancer, peritoneal primary tumor;Ascites were diagnosed by ultrasound or CT and confirmed malignant ascites by cytology;
✓. failed to standard systemic therapy and / or no appropriate treatment for the treatment for malignant ascites
✓. Age 18-70 years;
✓. Performance Status- Eastern Cooperative Oncology Group (ECOG)≤2;
✓. Life expectancy of at least 8 weeks;
Exclusion criteria
✕. systematic anti-cancer therapy, including chemotherapy (intraperitoneal chemotherapy), radiation therapy, immunotherapy, biological or hormone therapy performed within 2 weeks;
✕. tyrosine kinase inhibitors or monoclonal antibodies of anti-vascular endothelial growth factor (VEGF) performed within 4 weeks;
✕. Laboratory tests:Absolute neutrophil count\<1.0x109/L,Platelet count\<75x 109/L,Hemoglobin\<8g/dl,PT-INR≥1.5 times upper limit of normal (ULN);Bilirubin≥2 x ULN,AST and ALT≥2.5 times ULN(no liver metastasis),≥5 times ULN(with liver metastasis)Creatinine≥1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula,\<40 mL/min;
. Known history of severe heart disease,uncontrolled or symptomatic angina, congestive heart failure,clinically significant arrhythmias,myocardial infarction within six months;
✕. active (severe or uncontrolled) bleeding (hemorrhage within 3 months\> 30 ml), hemoptysis (fresh blood, 4 weeks\> 5 ml), bloody ascites