Gastrointestinal Stromal tumors
Conditions
Interventions
Case series:Imatinib mesylate
Sponsors
First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old male and female; 2. The diagnosis of gastrointestinal stromal tumors by histopathological examination, and immunohistochemical detection of CD117 and / or DOG - 1 is positive; 3. There is a measurable lesion that meets the recist 1.1 standard; 4. The tumor lesion was assessed as potential resection; 5. Untreated tyrosine kinase inhibitors including imatinibmesylate; 6. ECOG physical condition 0-2 points; 7. The patient informed consent and signed a written consent; 8. The patient is in good compliance and the patient's voluntary plan to receive follow-up visits, treatment, laboratory examinations and other research steps.
Exclusion criteria
Exclusion criteria: 1. PDGFRA gene exon 18 D842V mutation. 2. AST and/or ALT> 2.5 x ULN. 3. Serum total bilirubin > 1.5 x ULN. 4. Absolute count of neutrophil (ANC) 1.0 x ULN. 6. In the past five years, there have been 2 primary malignant tumors, except for the treatment of basal cell carcinoma of the skin or in situ carcinoma of the cervix. 7. Known brain metastasis, spinal cord compression, cancerous meningitis and other brain or soft meningeal diseases. 8. To enroll in the 12 months before with any of the following diseases: Myocardial infarction, severe/unstable angina pain, coronary artery/peripheral artery bypass surgery, with symptoms of congestive heart failure, or cerebrovascular accident. 9. The serum HIV antibody is positive. 10. Other clinical trials are currently being conducted. 11. Women who are pregnant or breastfeeding or have fertility but do not take contraceptive measures. 12. Suffering from other severe acute or chronic physiological or mental problems, or laboratory abnormalities, may add to the risk of participating in the study or use of the drug, or interfere with the judgment 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 (1 year);tumor shrinkagerate (1 year);Progression free survival rate in 2 years after resection;Correlation of serumconcentration of imatinibwith response;Organ function retention rate (1 year after enrollment);R0 resection rate (1 year);surgical morbidity and mortality (1 year);relationship between mutational status of lesions and efficacy ( 5 year );Safety and tolerability of neoadjuvant treatment with imatinib (2 years after enrollment);Overall survival rate ( 5 years ); | — |
Countries
China
Contacts
Public ContactZhang Xinhua
First Affiliated hospital of Sun Yat-sen University
Outcome results
None listed