adenoid cystic carcinoma
Conditions
Interventions
Lung metastasis prevention single medicine treatment group:all-transretinoic acid
Pulmonary metastasis control combined treatment group:all-transretinoic acid combined with low-dose anti-angiogenesis drugs
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathological diagnosis of glandular cystic cancer across Beijing Tongren Hospital affiliated to the Capital Medical University; 2. The original site is standardized by surgery+radiotherapy; any number of treatment in the past has been allowed, including chemotherapy, molecular targeted drugs, radio frequency discharge and treatment. However, patients must be 3 or 4 weeks before the group. The above complete radiotherapy or any systematic treatment; 3. Confirmation of MYB immunohistochemistry (the test and evaluation of all patients' immunohistochemicals are conducted by the Pathology Department of Beijing Tongren Hospital affiliated to the Capital Medical University for testing. 4. Aged 18-75 years, men or women who are not pregnant and non-lactating; 5. Consistent diagnosis standards for lung metastasis: After more than 2 times, the interval is > 3months CT, and found a malignant nodule of the lungs stable or continuously progressing; and patients with = 100 x 10^9/L; Hb >= 100 g/L; the absolute value of neutral granulocyte count >= 1.5 x 10^9/L), liver function (bilirubin <= 1.53 x ULN; Alt/AST <= 2.5 x ULN [Patients with liver metastases <= 5 x ULN], renal function (Cr <= 1.5 x ULN); 9. Alkaline phosphatase <= 4 x ULN, PT and APTT < 1.5 x ULN; 10. Women with fertility potential must conduct serum pregnancy test negative within 2 weeks before the start of the drug. Women who have menopausal women (defined as menstruation at least one year) and surgical surgery do not need to conduct pregnancy tests; 11. Patients (men and women) with fertility potential must agree to use appropriate contraceptive measures, starting from signing consent, until the last dose is studied at least 3 months. The definition of appropriate contraception will be based on the judgment of the main researchers or designated assistants; 12. The clinical data of the patient is complete; 13. Be able to study the visits to the timetable, and understand and rely on all the requirements of all experimental schemes; 14. Being able to sign the consent of informedness; 15. Patients must be able to swallow and retain oral drugs.
Exclusion criteria
Exclusion criteria: 1. Poor cardiopulmonary and kidney function; 2. Activities or clinically significant heart disease, including: congestive heart failure (level 3 or fourth level of the New York Heart Association); active coronary disease with no drug treatment; Cardiac disorders for arrhythmia; unstable coronary heart disease (symptoms of angina pectoris occurred during static breath), new angina pectoris occurred in the first three months of registration, and myocardial infarction occurred within the first June; 3. Throst or embolism in the past 6 months; 4. History or evidence of bleeding or coagulation disorders; 5. For major surgery, cut biopsy or major trauma within 28 days before the start of medication; 6. Severe clinical infection of activity (common term standard for adverse events [CTCAE] classification > 2); 7. Existing non-healing wound or non-healing ulcers that have nothing to do with tumors; 8. Vicious tumors accompanied by other progress; 9. Those who do not cooperate with serious mental illness; 10. Patients with breastfeeding or pregnancy; 11. As a subject to participate in the clinical trials of other drugs, the last test drug was given to the drug for the first time of this study; 12. Planning to receive any other anti-tumor treatment during this trial; 13. History of alien organ transplantation (including corneal transplantation); 14. It is known to allergies or germine in the vascular targeting drugs and full-type vitamin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distant metastasis-free survival;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ocal-regional recurrence-free survival;disease-free survival;progression free survival;Disease control rates;time to remission;Duration of remission;Rate of change in lung tumor nodule diameter;Number of new metastatic nodules; | — |
Countries
China
Contacts
Public ContactXiaohong Chen
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed