Thymoma
Conditions
Interventions
single arm:Alotinib
Sponsors
The First Hospital of Shijiazhuang
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75years, male or female; 2. Pathologically diagnosed thymus adenoma; 3. At present, CT and other imaging examinations have confirmed the recurrence of tumor after chemotherapy; 4. With a measurable lesion (helical CT scan > 10mm, meeting the RECIST 1.1 standard); 5. Easten Cooperative Oncology Group (ECOG ) performance status of 0-2; 6. Baseline blood routine and biochemical indicators meet the following criteria: HB >= 80 g/L, ANC >= 1.5 x 10^9 / L,PLT >= 90 x 10^9 / L; ALT and AST <= 2.5 ULN, but in patients with liver metastasis <= 5, TBIL <= 1.5, Serum Cr <= 1.5; serum total bilirubin acuities were 1.5 times the normal ceiling; serum creatinine acuities were 1.5 times the normal ceiling. 7. The predicted survival time is greater than or equal to 3 months; 8. Women of childbearing age must have taken reliable contraception or performed pregnancy test (serum or urine) within 7 days of admission ,with negative results ,and be willing to use appropriate method of contraception eight weeks after the trial period .For men, surgical sterilization or consent to use an appropriate method of contraception eight weeks after the trial period and the last administration of the trial drug; 9. The subjects volunteer to join the study and sign informed consent, have good compliance and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure > 140mmhg, diastolic blood pressure > 90mmhg), uncontrollable coronary heart disease and arrhythmia, and grade iii-iv cardiac dysfunction; 2. Multiple factors that affect oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction); 3. The patients with a clear tendency of gastrointestinal bleeding include the following situations: local active ulcer lesions, and fecal occult blood (++) cannot be included;A history of black stool and hematemesis within 2 months; 4. Abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN), with hemorrhagic tendency; 5. Pregnant or lactating women; 6. Patients who have a history of psychotropic drug abuse and cannot be cured or have mental disorders; 7. Have participated in the clinical trial within 4 weeks; 8. The researchers consider it unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;safety; | — |
Countries
China
Contacts
Public ContactGuoyan Qi
The First Hospital of Shijiazhuang
Outcome results
None listed