gastrointestinal stromal tumor
Conditions
Interventions
Experimental group:surgery+imatinib
control group:imatinib
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary GISTs can be or was already curatively resected; 2. Based on an understanding of hepatic anatomy and the extent of liver metastases, metastatic lesions can be completely removed while preserving adequate liver function (remnant liver volume >=30-40%); 3. Liver metastases can be completely removed with microscopically negative margin as evaluated by a multidisciplinary team consisted by experts specialized in related surgical techniques, radiology and interventional therapy; 4. Mutations are detected in c-kit or PDGFRa (not exon 18 D842V) using samples from biopsy or surgical specimens; 5. Imatinib is administrated for liver metastases after diagnosis or surgery; 6. Aged between 18 years and 75 years; 7. No other malignant tumors occurred in the last 5 years; 8. The ECOG PS score is fewer than 2 points and ASA score fewer than 3 points; 9. Informed consented can be obtained from patients or their legal representatives.
Exclusion criteria
Exclusion criteria: 1. The patient has other serious complications and could not tolerate surgery, such as severe cardiopulmonary disease, NYHA grade >II, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes mellitus and / or renal insufficiency, severe hepatitis and / or liver function, child Pugh grade C or grade B whose symptoms are obviously difficult to correct, and severe malnutrition; 2. Previous hepatic or extrahepatic metastases or recurrence; 3. Synchronous extrahepatic metastases; 4. Liver metastases that emerge on imatinib therapy; 5. Complications such as bleeding, perforation and obstruction occur; 6. Pregnant or lactating women; 7. Patients suffering from serious mental illness; 8. The patient has participated in or is participating in other clinical studies, or is using other TKI preparations.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 3yr OS rate;adverse event rate;quality of life; | — |
Primary
| Measure | Time frame |
|---|---|
| 3yr PFS rate; | — |
Countries
China
Contacts
Public ContactSHEN KUNTANG
Zhongshan Hospital, Fudan University
Outcome results
None listed