Gastrointestinal Stromal Tumors
Conditions
Interventions
Observation group:None
Sponsors
Department of General Surgery, The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients are voluntarily enrolled and sign a written informed consent form, with good compliance and cooperation with follow-up; 2. Histopathologically confirmed gastrointestinal stromal tumor; 3. Patients with histologically confirmed advanced gastrointestinal stromal tumors, according to mRECIST v1.1 criteria, subject with at least one measurable lesion (non-lymph node lesion long diameter>=1.0 cm or >= 2 times the thickness of the scanning layer); Lesions that have progressed clearly after local therapy can also be considered measurable; Imaging results must be obtained within 28 days prior to the first dose; 4. Currently taking or about to take ripretinib as a second- or late-line treatment for advanced gastrointestinal stromal tumors; 5. According to the NIH2008 grade, the tumor is at medium to high risk of recurrence; 6. ECOG score 0-2; normal function of vital organs; 7. 18 years old< = age< = 75 years;
Exclusion criteria
Exclusion criteria: 1. Patients with active infection, such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; 2. Pregnant or lactating patients; 3. Patients with severe organ insufficiency or ALT/AST exceeding 3 times of the upper limit of normal value; 4. Those who participated in other clinical investigators 4 weeks before the start of this study or participated in this study at the same time; 5. Subjects who withdraw for any reason cannot be re-enrolled in this study; 6. Gastrointestinal abnormalities, including but not limited to: inability to swallow study drugs, malabsorption syndrome, need for intravenous nutrition; 7. As judged by the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental illnesses) that require concurrent treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the patient's safety; 8. Other patients who may affect the conduct of clinical research, may not be able to comply with the protocol or cannot cooperate, and patients who are at risk of study; 9. Prior or current condition with other malignancies whose natural medical history or treatment may affect the evaluation of the safety or efficacy of ripastinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ripretinib drug concentration; | — |
Countries
China
Contacts
Public ContactHao Xu
Hao Xu is affiliated with the First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, Jiangsu 210029, P. R. China
Outcome results
None listed