Malignant tumor with ascites
Conditions
Interventions
6 units group:intraperitoneal perfusion with MTX packaging microparticles, 6 units per time, 5 times in a row
10 units group:intraperitoneal perfusion with MTX packaging microparticles, intraperitoneal perfusion with MTX packaging microparticles, 10 units per time, 5 times in a row
12 units group:intraperitoneal perfusion with MTX packaging microparticles, intraperitoneal perfusion with MTX packaging microparticles, 12 units per time, 5 times in a row
15 units group:intraperitoneal perfusion with MTX packaging microparticles, intraperitoneal perfusion with MTX packaging microparticles, 15 units per time, 5 times in a row
Sponsors
Union Hospital of Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who have been diagnosed as malignant tumors (except for liver cancer) by pathological and/or cytological examinations, combined with ascites; 2. Subjects whose ascites is confirmed to be 2-3 degrees by CT (EASL guidelines and ICA consensus) and need puncture drainage; 3. Exfoliated cytology of ascites found tumor cells; 4. Aged 18 to 75 years; 5. Subjects who have not received intraperitoneal local administration in the past 4 weeks; 6. Subjects with stable vital signs, Karnofsky score >= 70, and expected survival time greater than 3 months; 7. Bone marrow hematopoietic function is normal, HGB >= 90g/L, WBC >= 2.5x10^9/L, NEU >= 1.5x10^9/L, PLT >= 90x10^9/L; 8. The coagulation function is normal, and there is no bleeding tendency (prothrombin international standardized ratio INR = 60 ml/min; 11. The subject agreed to join the trial, and the compliance was good, and the informed consent form had been signed.
Exclusion criteria
Exclusion criteria: 1. Subjects with other serious heart, lung or vascular system diseases that may affect the treatment effect; 2. Subjects with a history of extensive adhesions in the abdominal cavity, encapsulated ascites, intestinal obstruction or intestinal perforation; 3. Subjects with liver metastatic cancer; 4. Cachexia subjects with extensive distant metastasis in the terminal stage; 5. Subjects who are receiving targeted drug therapy or immunotherapy; 6. Subjects who are breastfeeding, pregnant or preparing to become pregnant; 7. Subjects with severe hypoalbuminemia and plasma albumin (ALB) < 30g/L; 8. Subjects who have had hypoproteinemia, decreased white blood cells, decreased platelets or decreased red blood cells due to chemotherapy and other reasons, and have received symptomatic treatment within 2 weeks; 9. Subjects who are known to be allergic to test sample components or their analogs; 10. Subjects who suffer from other severe, acute or chronic diseases that may interfere with the interpretation of the research results and who are judged by the investigator to be unsuitable to participate in clinical trials; 11. Subjects with cognitive dysfunction or poor compliance with treatment as determined by the investigator; 12. Those who have participated in other clinical trials within 4 weeks; 13. Subjects deemed unsuitable to participate in clinical trials by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum safe tolerated dose and safe tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate of ascites of malignant ascites;Tumor markers in ascites;Quality of life; | — |
Countries
China
Contacts
Public ContactZhang Tao
Outcome results
None listed