Malignant Ascites
Conditions
Interventions
experimental group:Recombinant Human Adenovirus 5 Injection (Oncorine)
Sponsors
Jilin Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate, sign an informed consent form, have good compliance, and be able to cooperate with diagnosis, treatment, and follow-up. 2.Age = 18 years at time of study entry, male or female. 3.Advanced malignant tumors are diagnosed by pathological histology and/or cytological examination, with malignant ascites assessed by the investigator to require treatment. Malignant ascites is defined as the presence of tumor cells visible in the cytologic examination. 4.Moderate or greater amount of abdominal effusion confirmed by computer tomography (CT) or B-ultrasound, and local treatment for abdominal effusion is clinically necessary. Moderate amount or above effusion is defined as a maximum depth of abdominal effusion = 4cm on B-ultrasound examination in supine position, and estimated ascites volume >500mL by CT scan. 5.Cooperative Oncology Group-Status (ECOG Status) = 2.Participants with a score of 3 were included if the investigator determined that the ECOG score of the subject with the removal of the ascites fell to 2 or below. 6.Life expectancy=3 months. 7.The main organ functions are basically normal, and laboratory tests meet the following standards: a) Absolute neutrophil count = 1.5×10^9/L, Platelets =75×10^9/L; Hemoglobin=90 g/L. b) Renal Serum Creatinine = 2.0 ULN and creatinine clearance (CrCl) > 60 mL/min (use the Cockcroft-Gault formula). c)Total bilirubin <2×ULN; patient with no liver metastasis: AST and ALT<2.5×ULN;patient with liver metastasis: AST and ALT<5×ULN. d)International normalized ratio (INR) of coagulation function or prothrombin time (PT) < 1.5 × upper limit of normal (ULN). If the subject is receiving anticoagulant therapy, the coagulation index needs to be within the range of anticoagulant drug use, and the investigator needs to evaluate that it will not increase the risk of participating in this study to undergo abdominal puncture catheterization. 8.Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of the trial; Female/male subjects with reproductive ability must be willing to adopt reliable contraceptive methods throughout the entire study period (from screening to 90 days after the last administration of the study drug), including but not limited to abstinence, the male partner has undergone vasectomy, female sterilization surgery, effective intrauterine device, and effective contraceptive drugs.
Exclusion criteria
Exclusion criteria: 1.Have participated in or received study treatment in another clinical study within the 4 weeks prior to current participation or first administration of study treatment. 2.Received systemic anti-tumor therapy or intraperitoneal drug therapy within the first 28 days prior to the first intracavitary administration. 3.Accompanied by grade >1 AE with unrecovered pre-treatment, unless some grade 2 AE judged by the investigator to be stable and unable to recover to a lower level, and does not affect the safety of the subjects participating in this study, such as hair loss. 4.Subjects who have undergone other major surgeries, except for diagnosis or biopsy, within 28 days prior to the first administration of the drug or are expected to undergo major surgeries during the study period. 5.Encapsulated abdominal effusion. 6.History of intestinal adhesions, or occurrence of Ileus within 30 days prior to initial administration. 7.Malignant liver tumor. 8.Arterial or venous thromboembolic disease. 9.History of serious cardiovascular and cerebrovascular diseases, including but not limited to: o Within the past 6 months, there has been a myocardial infarction or current presence of unstable angina, arrhythmia, etc. o Congestive heart failure with New York Heart Association (NYHA) cardiac functional classification = II. o Left Ventricular Ejection Fractions 10 mg/day or equivalent) or any other form of immunosuppressive therapy. The following conditions can be enrolled after evaluation by the investigator: clinically stable autoimmune thyroid disease; use of local corticosteroids for eye, joint, nasal, etc.; short-term use of corticosteroids for prophylactic treatment; physiological dose of hormone replacement therapy. 17.The existence of medical history or diseases, treatments or laboratory abnormalities that may interfere with research results or hinder the full participation of subjects in the study, or that the investigator believes participation in the study is not in the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose;Dose-limiting Toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics and the virus shedding of Recombinant Human Adenovirus 5 Injection (Oncorine) in patients with malignant ascites by intraperitoneal infusion;Objective Response Rate;Time to Repeat Paracentesis; | — |
Countries
China
Contacts
Public ContactYing Cheng
Jilin Provincial Cancer Hospital
Outcome results
None listed