Gastrointestinal stromal tumors
Conditions
Interventions
Combination therapy group:Rapatinib 150 mg combined with Sunitinib 25 mg qd
Ruipaitiniga dosage group:The patient is taking 150mg bid of Rapatinib
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.>=18-year-old GIST patients, male or female; 2. Receiving fourth-line drug therapy (first-line: imatinib; Second line: sunitinib; Third line: regorafenib; Fourth-line: ripretinib) failed in patients with advanced GIST; 3. Undergo blood NGS sequencing; 4. Subject has at least one measurable lesion (non-lymph node lesion length diameter >=1.0 cm or >=2 times the thickness of the scan layer) according to mRECIST v1.1 criteria; 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; 5. Voluntarily agree to participate in the study and sign the informed consent form; 6. The function of major organs is normal, and the subjects must meet the following laboratory indicators: 1) Absolute neutrophil value (ANC) >=1.5x10^9/L in the absence of granulocyte colony-stimulating factor in the past 14 days; 2) Platelet >=100×10^9/L without blood transfusion in the past 14 days; 3) Hemoglobin >9g/dL in the absence of blood transfusion or erythropoietin use in the past 14 days; 4) Total bilirubin 1.5xULN but direct bilirubin =60 ml/min; 7) good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled; 9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to be enrolled); 7. European Cooperative Oncology Group (ECOG) daily living ability score of 0 or 1; 8. Non-surgically sterile or female patients of childbearing potential who are required to practice one medically approved form of contraception (such as an intrauterine device, birth control pill, or condom) during study treatment and for 90 days after the end of study treatment; Non-surgically sterilized female patients of childbearing potential must have a negative serum HCG within 72h prior to randomization; and must be non-lactating; For male patients whose partner is a woman of childbearing potential, an effective regimen of contraception should be used during study treatment and for 90 days after the end of the study treatment period. 9. Willing and able to comply with trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Taking other tyrosine kinase receptor inhibitors other than fourth-line drugs; 2. Patients who do not follow the doctor's instructions, do not use drugs according to the regulations, or have incomplete information that may affect the judgment of efficacy or safety; 3. Pregnant or lactating female patients; 4. Patients with other malignant tumors within 5 years prior to enrollment, except for the following: malignant tumors that can be expected to heal after treatment (cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, stage I lung cancer, stage I colorectal cancer, etc., can be enrolled; ) 5. Other severe, uncontrollable concomitant diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease (grade III or IV heart failure as defined by the New York Heart Association classification, heart block above grade II, myocardial infarction within the past 12 months, unstable arrhythmia or unstable angina, cerebral infarction within 6 months, etc.) or pulmonary disease (interstitial pneumonia, history of obstructive pulmonary disease and symptomatic bronchospasm), deep vein thrombosis or pulmonary embolism within 6 months; 6. It is estimated that the compliance of participating in this clinical study is insufficient, and the patient has other factors that may affect the results of the study or cause the study to be forced 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 safety of the patient. 7. Other patients who may affect the conduct of clinical research, may not be able to comply with the protocol or those who cannot cooperate, and patients who are at risk of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Objective response rate (ORR);Safety and tolerability; | — |
Countries
China
Contacts
Public ContactXu Hao
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed