Malignant pleural and peritoneal mesothelioma
Conditions
Interventions
Experimental group:Bevacizumab combined with systemic chemotherapy
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Malignant mesothelioma diagnosed by histopathology, accompanied by pleural and ascites effusion (a moderate amount or more on ultrasound exploration); 3. ECOG PS: 0-1 points; 4. The expected survival period is >=3 months; the patient has systemic treatment indications and no contraindications; 5. The patient can understand and sign the informed consent form (when the subject is incapacitated, it will be signed by his legal representative).
Exclusion criteria
Exclusion criteria: 1. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA grade 2 or higher heart failure; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; (5) QTc>450ms (male); QTc>470ms (female); 2. Patients who are pregnant or breastfeeding; 3. Patients with known mental illness or substance use disorder; 4. According to the judgment of the researcher, the subjects have other factors that may lead to the forced termination of the study, for example: there are serious abnormal laboratory examinations, accompanied by family or social factors, which will affect the safety of subjects, or the collection of data and samples; 5. Any life-threatening bleeding events within the past 3 months, including the need for blood transfusion therapy, surgery or local therapy, and continuous drug therapy; 6. Arterial and venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other history of severe thromboembolism. Implantable venous port or catheter-derived thrombosis, or superficial vein thrombosis, except those with stable thrombus after conventional anticoagulation therapy. Prophylactic use of low-dose low-molecular-weight heparin (eg, enoxaparin 40 mg/day) is permitted; 7. Within 2 weeks before the first dose, use aspirin (> 325 mg/day) for 10 consecutive days with drugs known to inhibit platelet function, such as dipyridamole or clopidogrel; 8. Uncontrollable hypertension, systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 9. Severe bleeding tendency or coagulation dysfunction, or are receiving thrombolytic therapy; 10. History of gastrointestinal perforation and/or fistula within the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), wide bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival;Overall survial;Adverse event; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed