malignant ascites
Conditions
Interventions
drug MP:intraperitoneal perfusion of MTX-MP
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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 for liver cancer) ; 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 >= 60, and expected survival time > 3 months; 6. patients aged 18-80 years; 7. normal bone marrow hematopoietic function, HGB >= 90g/L, WBC > 4.0x10^9/L(NEU >=1.5x10^9/L)PLT >= 80x10^9/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; 12. 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: 1. combined with serious cardiopulmonary disease; 2. extensive abdominal adhesion; encapsulated peritoneal effusion; intestinal obstruction; history of intestinal perforation; cachexia patients with distant and extensive metastasis at the end stage; 3. women who are breastfeeding, pregnant or preparing for pregnancy; 4. patients who are known to be allergic to the composition of the test sample or its analogues; 5. patients with other severe, acute or chronic diseases that may interfere with the interpretation of the study results; 6. patients with cognitive impairment or poor treatment compliance determined by the researcher; 7. patients who participated in other clinical trials within 4 weeks; 8. 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;Ascites control time;Ascites property; | — |
Countries
China
Contacts
Public ContactHu Liu
Anhui Provincial Cancer Hospital
Outcome results
None listed