Malignant ascites
Conditions
Interventions
Test group A:Single-drug intracavitary injection of recombinant human adenovirus type 5 injection
Test group B:Cisplatin single-drug intracavitary injection
Sponsors
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with malignant tumor confirmed by cytology or histology; 2. Malignant peritoneal effusion with a moderate amount or more, the definition of a moderate amount: the maximum depth of the liquid dark area of the B-ultrasound examination is >= 5cm, and the non-encapsulated effusion; 3. Age from 18 to 75 years old; 4. ECOG PS is 0-2 points, and the expected survival time is >= 3 months; 5. Routine blood examination standards must meet: absolute neutrophil count (ANC) >= 2 x 10^9/L and platelet count >= 100 x 10^9/L and hemoglobin >= 9 g/dL; 6. The biochemical inspection shall meet the following standards: 1) Total bilirubin 60ml/min (Cockcroft-Gault formula); 7. The coagulation function test must meet the following standards: APTT < 45s, PT < 16s, FIB < 5g/L, D-Dimer < 2mg/L; 8. The electrocardiogram is basically normal, the blood pressure is well controlled, and there is no unhealed wound on the body; 9. For patients who have undergone surgery in the past, it is required that more than 4 weeks have passed since the start of the study treatment, and the patient has recovered; 10. Patients who have received radiotherapy, chemotherapy, targeted therapy, immunotherapy and other anti-tumor treatments in the past are required to have more than 4 weeks since the start of the study treatment; 11. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Ascites caused by other non-tumor reasons, such as cirrhotic ascites, tuberculous ascites, etc.; 2. Pregnant or lactating women, or female patients who have fertility but have not taken contraceptive measures; 3. Those who have serious acute infections that have not been controlled, or have purulent and chronic infections, and the wounds are prolonged and unhealed; 4. Pre-existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and refractory hypertension; 5. Those who suffer from uncontrollable neurological or mental diseases or mental disorders, have poor compliance and cannot cooperate and describe the treatment response; primary brain tumors or central nerve metastases have not been controlled, and have obvious intracranial hypertension or neuropsychiatry Symptoms; 6. Those who have a history of allergy to similar biological agents; 7. Those who are using antiviral drugs or high-dose adrenal glucocorticoids; 8. People with immunodeficiency and immunosuppression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal fluid quantification;Quality of Life Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral blood count;Blood biochemical test;Coagulation function test;Urine test;Quality of Life Scale; | — |
Countries
China
Contacts
Public ContactLi Xiaojiang
the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed