Advanced gastric cancer
Conditions
Interventions
Interventional group:Direct cryotherapy at tumor site
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed as advanced gastric cancer (AJCC 8th edition, stage IV), no effective therapeutic option and limited prognosis for existing therapy (18 years and 3 months; 5. Vital organ function must meet (1) Normal cardiac function (echocardiography shows ejection fraction >=50%, no obvious abnormality is seen on ECG); (2) Normal pulmonary function (normal vital capacity (VC) and total lung capacity (TCL)); (3) Normal hepatic function: ALT and AST=40ml/min using Cockcroft–Gault formula; 6. Complete blood cell count: Hgb>=70g/L, ANC>=1.5*10^9/L, PLT>=80*10^9/L; 7. Coagulation function: PT and APPT92%; 8. Negative pregnancy test for women of childbearing potential; 9. ECOG score <=2; 10. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women or women with pregnancy plan within half a year; 2. Infectious disease (e.g., HIV, RPR, active tuberculosis); 3. Active hepatitis B or hepatitis C; 4. Combined with other primary malignant tumors; 5. Having participated in other clinical trials within 1 month; 6. Intake of antiplatelet or anticoagulant drug within one week; 7. Presence of other reasons for inability to be enrolled, as considered by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure complication;Incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor size under endoscopy;Tumor size and FDG uptake rate;Overall survival;Progression-Free-Survival;The remission rate in Day 28 and Day 91;Disease control rate; | — |
Countries
China
Contacts
Public ContactLiu Jie, Luo Zhongguang
Outcome results
None listed