Malignant ascites
Conditions
Interventions
Experimental group A:Intracavitary single injection of recombinant human adenovirus type 5 20.0×1011vp, dilute with normal saline to 20ml
Experimental group B:Intracavitary single injection of cisplatin 30mg, dilute with normal saline to 20ml
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 tumors confirmed by cytology or histology; 2. Combined with more than moderate amount of malignant ascites, the definition of moderate amount: the maximum depth of the dark area of iquid in B-ultrasound examination is >= 5cm, and it is non-encapsulated effusion; 3. Aged 18-75 years; 4. ECOG PS 0-2 points, expected survival period >= 3 months; 5. The standard of blood routine examination should meet: absolute neutrophil count (ANC)>=2x10^9/L and platelet count>=100x10^9/L and hemoglobin >= 9g/dL; 6. Biochemical tests should meet the following criteria: total bilirubin 60ml/min (Cockcroft-Gault formula); 7. The coagulation function test should meet the following criteria: 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 elapsed since the start of the study treatment, and the patient has recovered; 10. For patients who have received anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, and immunotherapy in the past, it is required that more than 4 weeks have elapsed since the start of the study treatment; 11. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Ascites caused by other non-tumor causes, such as cirrhotic ascites, tuberculous ascites, etc.; 2. Pregnant, lactating women, or female patients who are fertile but not taking contraceptive measures; 3. Existing severe acute infection that has not been controlled, or purulent and chronic infection with persistent wound healing; 4. Those with uncontrollable neurological, mental diseases or mental disorders, poor compliance, unable to cooperate and describe the response to treatment; uncontrolled primary brain tumor or central nervous system metastases, with obvious intracranial hypertension or neuropsychiatric symptoms symptomatic; 5. Those with a history of allergy to similar biological agents; 6. Those who are using antiviral drugs or high-dose adrenal glucocorticoids; 7. Immunodeficiency and immunosuppression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Progression (TTP);Quality of Life (QoL); | — |
Countries
China
Contacts
Public ContactLi Xiaojiang
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed