Malignant tumors of digestive tract with malignant ascites
Conditions
Interventions
Single Group:Intraperitoneal implantation of sustained-release fluorouracil
Sponsors
Renmin Hostipal of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Malignant tumors of digestive tract were diagnosed by histopathology/cytology, and ascites cytology could detect the elevation of tumor cells or tumor markers. 2) Complicated with moderate or higher amount of peritoneal effusion, lost the chance of operation. Initial treatment or intracavitary administration of conventional chemotherapeutic drugs and/or biological response regulators were ineffective. Definition of moderate ascites: the same physician (in principle), supine position B-mode ultrasonography examination of ascites maximum depth (>= 3 cm), and accompanied by clinical symptoms (chest tightness, shortness of breath, abdominal distension discomfort). 3) The age ranged from 18 to 75 years. 4) ECOG score 0-2, combined with FOLFOX4 except fluorouracil, ECOG score > 2. 5) The estimated survival time is more than 2 months. 6) The function of the main organs is normal, which meets the following criteria. The standard of blood routine examination should be in conformity with: A. Hemoglobin (>= 9.0g/dL); B. Leukocyte count (>=4.0 *10^9/L); C. Granulocyte absolute count (>=1.5 *10^9/L); D. Platelet count (>= 80 *10^9/L). Biochemical tests should meet the following criteria: A. Total bilirubin 60 ml/min (Cockcroft-Gault formula) 7) Voluntary admission, signing informed consent, good compliance, with follow-up. 8) Distance from major operation for more than 4 weeks.
Exclusion criteria
Exclusion criteria: 1) Complicated with uncontrolled metastasis of the central nervous system, with high intracranial pressure. 2) Having the tendency of bleeding, especially the obvious gastrointestinal bleeding within 4 weeks, or being treated with thrombolysis or anticoagulation. 3) Use of other research drugs within 30 days or participate in other clinical studies at the same time. 4) Myocardial infarction or unstable angina pectoris or cardiac insufficiency occurred within 6 months. 5) Complicated with severe chronic obstructive pulmonary disease and/or respiratory failure, severe intestinal adhesion. 6) Patients with poor compliance or mental illness can not control themselves. 7) Allergies to the drug and its excipients are known. 8) There are serious uncontrolled infections. 9) Female patients during pregnancy or lactation, who are unwilling to take contraceptive measures, are of childbearing age (including males). 10) Ineffective treatment of fluorouracil and its derivatives in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life;time to progression; | — |
Countries
China
Contacts
Public ContactGe Wei
Renmin Hostipal of Wuhan University
Outcome results
None listed