gastrointestinal stromal tumor
Conditions
Interventions
Experimental group:Ripatinib
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patients were voluntarily enrolled and signed a written informed consent, with good compliance and cooperation with follow-up; 2. Aged >= 18 years (calculated on the day of signing informed consent), no gender limit; 3. Patients with advanced gastrointestinal stromal tumor confirmed by histology, according to the mRECIST v1.1 standard, the patient has at least one measurable lesion (long diameter of non-lymph node lesions >= 1.0 cm or >= 2 times the scanning slice thickness); lesions with definite progression after topical therapy can also be considered measurable lesions; imaging results must be obtained within 28 days before the first dose; 4. The patient has disease progression or intolerance after receiving one or more TKIs including imatinib in the past; 5. Patients with two or more KIT/PDGFRA gene mutations; Note: If there are no archived tumor tissue samples, those who have a high risk of biopsy after assessment by the investigator and who can provide a previous KIT/PDGFRA test report can also be screened for inclusion; 6. The patient's ECOG physical status score is 0-2; 7. Good organ function and bone marrow reserve function, including: neutrophil count >=1.5x10^9/L, hemoglobin >=90 g/L, platelets >=100x10^9/L, total bilirubin =50 mL/min (calculated according to Cockcroft-Gault formula), prothrombin time (PT), international normalized ratio (INR) and partial thromboplastin time =50%; 8. Non-surgical sterilization or female patients of childbearing age, need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms) during the study treatment and within 90 days after the end of the study treatment; non-surgical sterilized female patients of childbearing age must be negative for serum HCG within 72 hours before randomization; and must be non-breastfeeding; for male patients whose partner is a woman of childbearing age, an effective contraceptive regimen should be used during the study treatment period and for 90 days after the end of the study treatment period.
Exclusion criteria
Exclusion criteria: 1. Previous use of Ripatinib. 2. Past or current patients with other malignancies whose natural history or treatment may affect the assessment of the safety or efficacy of Ripatinib. 3. New York Heart Association (NYHA) class II to IV heart disease, active myocardial ischemia or other poorly controlled heart disease such as angina pectoris, clinically significant arrhythmia requiring treatment, poorly controlled high blood pressure or congestive heart failure. 4. Arterial thrombosis or embolic events, such as cerebrovascular accident (including ischemic attack) or hemoptysis, occurred within 6 months before the first dose. 5. Venous thrombotic events (such as deep vein thrombosis) or pulmonary artery events (such as pulmonary embolism) within 3 months before the first dose; patients who had a venous thrombotic event >=3 months prior to the first dose and were receiving conventional anticoagulation were eligible for enrollment. 6. A history of long QT syndrome. 7. Major surgery (such as abdominal laparotomy) has been received within 4 weeks before the first dose; if the major surgery is performed >4 weeks after the first dose, all surgical wounds must be healed and there is no infection or dehiscence. 8. Currently suffering from any clinically significant comorbidities, such as uncontrolled lung disease, active infection or any other disease that the investigator believes may affect patient compliance, interfere with the interpretation of study results, or expose patients to safety risks. 9. Active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc. 10. Known hypersensitivity to any component of the study drug. Patients with Stevens-Johnson syndrome on prior TKI therapy should be excluded. 11. Gastrointestinal abnormalities, including but not limited to: inability to swallow study drug malabsorption syndrome requiring intravenous nutrition. 12. Any active bleeding, excluding hemorrhoids or bleeding gums. Present with any clinically significant comorbidity, such as uncontrolled lung disease, active infection, or any other disease that the investigator believes may affect patient compliance, interfere with the interpretation of study results, or expose the patient to safety risks. 13. According to the judgment of 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 diseases) that require combined treatment, there are serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients. 14. The investigator judges other patients who may affect the clinical research, may not be able to comply with the protocol, or who cannot cooperate, and who have research risks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactXu Hao
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed