gastric cancer
Conditions
Interventions
experimental group:intraperitoneal paclitaxel thermoperfusion chemotherapy
Sponsors
The Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients: >= 18 and = 3 months; 6. Major organs have good function, that is, relevant examination indexes within 14 days before randomization meet the following requirements: A) Routine blood test: I. Hemoglobin >= 90 g/L (no blood transfusion within 14 days); Ii. Neutrophils count >1.5 x 10^9 / L; III. Platelet count >= 100 x 10^9/L; B) Biochemical examination: I. Total bilirubin = 60 mL /min (Cockcroft-Gault formula); C) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%. 7. Signed the informed consent; 8. Good compliance, family members agree to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Participated in other drug clinical trials within 4 weeks; 2. A condition in which severe abdominal adhesion for a variety of reasons leads to an increased risk of intestinal puncture; 3. Abdominal adhesions form an impenetrable partition, allowing the amount of water injected.1000 ml; 4. Patients with known CNS metastases or a history of CNS metastases prior to screening.For patients with clinically suspected CNS metastases, CT or MRI examination must be performed within 28 days before randomization to exclude CNS metastases; 5. Patients with hypertension who were not well controlled by single antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); With a history of unstable angina pectoris;Patients newly diagnosed with angina pectoris within 3 months before screening or patients with myocardial infarction within 6 months before screening;Arrhythmias (including QTCF: male >= 450 ms, female >= 470 ms) require long-term use of antiarrhythmic drugs and New York Heart Association grade >= II cardiac insufficiency; 6. It should not be used when inflammatory lesions are estimated in the abdominal cavity. 7. The subject has other unresectable visceral metastases as shown by imaging; 8. Patients with abnormal coagulation function and bleeding tendency (14 days before randomization must meet: INR within the normal range without the use of anticoagulants);Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs;The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for prophylactic purposes is permitted, provided that INR is less than 1.5; 9. For female subjects, surgical sterilization, postmenopausal patients or consent to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period;Serum or urine pregnancy test must be negative within 7 days prior to study enrollment and must be non-lactation.Male Subjects: Patients who should be surgically sterilized or have agreed to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period. 10. Previous thyroid dysfunction, even in the case of drug treatment, thyroid function still can not be maintained within the normal range; 11. People with a history of abuse of psychotropic substances and unable to abstain from them or with mental disorders; 12. Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 13. Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Life quality;CA125, CA199, CEA;Adverse events; | — |
Countries
China
Contacts
Public ContactDongyan Cai
Affiliated Hospital of Jiangnan University
Outcome results
None listed