Gastrointestinal stromal tumor
Conditions
Interventions
preoperative IM treatment group:preoperative IM treatment
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years male and female; 2. Pathological diagnosis of GIST,with immunohistochemicalstain positive of CD117 and/or DOG - 1; 3. There are measurable lesions that conform to RECIST1.1 standard; 4. Locally advanced, potentially resectalbleGISTs: Gastroesophageal junction lesions requiring total or proximal partial gastrectomy; duodenal lesion > = 5 cm or requiringpancreatoduodenectomy; any lesion > = 10 cm; lower rectal lesions>=5 cm or requiring abdominal perineal resection(APR); 5. Not receiving any of treatment from tyrosine kinase inhibitors, including imatinib mesylate; 6. ECOG performance status 0-2; 7. The patient is informed consent and willing to sign a written consent; 8. Patients are willing to follow treatment, laboratory examination, and other research steps.
Exclusion criteria
Exclusion criteria: 1. GIST that mutation is D842V of exon 18 of PDGFRA; 2. AST and / or ALT > 2.5 times ULN; 3. Serum total bilirubin > 1.5 times ULN; 4. Absolute count of neutrophil ( anc ) 1.0 times ULN; 6. In the past five years, there was a second primary malignancy, with the exception of fully treated skin basal cell carcinoma or cervical carcinoma in situ; 7. Brain metastases, spinal cord compression, cancerous meningitis; 8. In the last 12 months, the patients has had any of the following diseases or conditions: myocardial infarction, severe / unstable angina, coronary artery / peripheral artery bypass , symptomatic congestive heart failure or cerebrovascular accident; 9. HIV positive; 10. The patient has been participated other clinical trials; 11. Pregnant or lactating women or having fertility but not taking birth control measures; 12. Suffering from other severe acute or chronic physiological or mental problems, or laboratory abnormalities, may increase the risk associated with the study or use of drugs, or interfere with the determination of the results of the study, and, as the researchers judge, it is not appropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;tumor shrinkagerate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival rate;Correlation between drug concentration and efficacy; | — |
Countries
China
Contacts
Public ContactXinhua Zhang
Outcome results
None listed