malignant ascites
Conditions
Interventions
Group of TMPs-MTX:intraperitoneal perfusion with TMPs-MTX
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: The patients met all the following inclusion criteria to could be allowed to participate in this clinical study: (1) ascites was confirmed by B-ultrasound, and the degree of ascites was 2 and 3 (EASL guide and ICA consensus); (2) patients diagnosed as malignant tumors of the digestive system (except liver cancer) by pathology or clinical diagnosis and found tumor cells by ascites abscission cytology; (3) at least one standard antitumor regimen has been performed; (4) patients who had not received local intraperitoneal administration within 4 weeks; (5) stable vital signs, Karnofsky score 60, and expected survival time >3 months; (6) patients aged 18-80 years; (7) normal bone marrow hematopoietic function, HGB=90g/LWBC>4.0×10^9/L(NEU=1.5×10^9/L)PLT=80×10^9/L (8) normal coagulation function without bleeding tendency (INR<1.5); (9) liver function: upper limit of normal value (ULN) of total bilirubin 1.5 times; AST and ALT 2.5 times normal upper limit (ULN) Upper limit of normal value (ULN) of alkaline phosphatase 1.5 times; (10) renal function: Cr 1.5 times normal upper limit (ULN) or creatinine clearance 60mL/min; (11) patients must obtain a written informed consent, signed and dated by themselves, before giving any operation related to the clinical study.
Exclusion criteria
Exclusion criteria: Patients with one of the following conditions cannot enter or continue the study: (1) extensive abdominal adhesion; Encapsulated peritoneal effusion; Intestinal obstruction.History of intestinal perforation; Cachexia patients with distant and extensive metastasis at the end stage; (2) combined with other serious cardiopulmonary diseases, etc.; (3) women who are breastfeeding, pregnant or preparing for pregnancy; (4) patients with plasma albumin (ALB) < 30g/L and severe hypoalbuminemia; (5) patients who are known to be allergic to the composition of the test sample or its analogues; (6) patients with other severe, acute or chronic diseases that may interfere with the interpretation of the study results; (7) patients with cognitive impairment or poor treatment compliance determined by the researcher; (8) patients who participated in other clinical trials within 4 weeks; (9) patients whom the researchers consider it inappropriate to conduct clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR of malignant ascites; | — |
Secondary
| Measure | Time frame |
|---|---|
| QoL;Tumor markers in ascites; | — |
Countries
China
Contacts
Public ContactYing Hongyan
Department of Medical Oncology, Peking Union Medical College Hospital
Outcome results
None listed