Gastrointestinal stromal tumor
Conditions
Interventions
Case series:Apatinib 500mg qd
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed metastatic gastrointestinal stromal tumor; 2. There is RECIST1.1 evaluable lesion; 3. Received c-kit/PDGFRA gene detection; 4. Aged 18 years old or older, male or female; 5. Imatinib treatment failure or sunitinib treatment can not tolerate; 6. ECOG PS 0-1 points; 7. The main organs function normally and meet the following requirements: (1) Blood routine examination, need to meet (no blood transfusion within 14 days): HB=80g/L; ANC =1.5×10^9/L; PLT =80×10^9/L; (2) Biochemical examinations must meet the following criteria: BIL <1.5 times the upper limit of normal (ULN); ALT and AST < 2.5 × ULN; if there is liver metastasis, ALT and AST < 5 × ULN; Serum Cr=1×ULN, endogenous creatinine clearance =50ml/min (Cockcroft-Gault formula); 8. Estimated survival time = 3 months; 9. Surgery = 4 weeks, and the wound has completely healed; 10. Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment. And voluntarily use the appropriate method of contraception during the observation period and within 8 weeks after the last administration of apatinib tablets; for males, should be surgical sterilization, or agree to use appropriate within 8 weeks after the observation and the last administration of apatinib tablets method of contraception; 11. Patients volunteered to participate in the study and signed an informed consent form (ICF) with good compliance and cooperation for follow-up.
Exclusion criteria
Exclusion criteria: 1. People who have had other malignant tumors in the past or at the same time; 2. People with hypertension who cannot be reduced to normal range by antihypertensive drugs (systolic blood pressure >140 mmHg)/ diastolic blood pressure > 90 mmHg), with coronary heart disease = grade II, arrhythmia (including QTc interval extension male>450 ms, female>470 ms) and cardiac insufficiency; 3. A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic abdomen) Diarrhea and intestinal obstruction, etc.); 4. Patients who have a high risk of gastrointestinal bleeding may not be enrolled by the investigator; 5. abnormal blood coagulation (INR > 1.5 × ULN, APTT > 1.5 × ULN), with bleeding tendency; 6. Anastomosis recurrence; 7. Patients with mental illness or history of psychotropic substance abuse; 8. Pregnant or lactating women; 9. Other patients considered by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS; | — |
Countries
China
Contacts
Public ContactCao Dan
West China Hospital, Sichuan University
Outcome results
None listed